Science & Research

Safety Report Updates

Listed below are the products that have had a report on adverse events presented to the Pediatric Advisory Committee(PAC). Click on the drug name to go to the meeting materials. Each column is sortable by the arrow. The table is searchable by keyword (e.g., drug name, PAC date, or recommendation(s)).

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Product Pediatric Labeling Change or Exclusivity Granted* Date Type of Presentation Presentation Date Pediatric Advisory Committee Recommendations and Subsequent Outcomes
Zoloft (sertraline)16 02/01/2002 Meeting 06/12/2003 June 12, 2003- Pediatric Subcommittee (PS) in conjunction with the Psychopharmacologic Drugs Advisory Committee (PDAC) requested re-analysis of Selective Serotonin Reuptake Inhibitor (SSRI) data once the cases are reclassified and for FDA to issue a warning in the interim on the potential side effects of the SSRIs.
February 3, 2004 - PS agreed to future update on SSRIs, neonatal withdrawal, and eye malformation;
On March 22, 2004 - FDA issued a Public Health Advisory; Antidepressant Public Health Advisory
June 9, 2004 - PS endorsed class labeling for neonatal toxicity/withdrawal syndrome;
September 13, 2004 - PAC in conjunction with the PDAC Neuropsychiatry Committee after reviewing the re-analysis of pediatric cases suicidality, the committee voted for a MedGuide and "black box" warning to be applied to all antidepressants.
October 15, 2004 - FDA directs manufacturers of all antidepressant medications to add a "black box" warning and develop a patient medication guide (MedGuide). See templates for proposed changes labeling Antidepressant Public Health Advisory 10.15.2004 and MedGuide (historical information scroll down for MedGuide template).
Atropine Sulfate Opthalmic Solution, UPS 1% 07/18/2014 Web 03/03/2018 FDA will continue post-marketing safety surveillance.
Emend (aprepitant) Capsule and Oral Suspension 8/28/2015 Web 03/05/2018 FDA will continue post-marketing safety surveillance.
Epicel (cultured epidermal autografts) 02/18/2016 Web 03/05/2018 FDA will continue post-marketing safety surveillance.
Epiduo Forte (adapalene/benzoyl peroxide, 0.3%/2.5%) gel 07/15/2015 Web 03/05/2018 FDA will continue post-marketing safety surveillance.
Flourish Pediatric Esophageal Atresia Device 05/12/2017 Web 03/05/2018 FDA will continue post-marketing safety surveillance.
Gadavist (gadobutrol); Eovist or Primovist (gadoxetate disodium) 12/29/2014;
04/27/2016, 03/27/2015
Web 03/05/2018 FDA will continue post-marketing safety surveillance.
Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) 12/10/2014 Web 03/05/2018 FDA will continue post-marketing safety surveillance.
Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) oral tablets 11/05/2015 Web 03/05/2018 FDA will continue post-marketing safety surveillance.
Kapvay (clonidine extended-release) tablets 11/20/2014& 08/16/2016 Web 03/05/2018 FDA will continue post-marketing safety surveillance.
Nucala (mepolizumab) 11/04/2015 Web 03/05/2018 FDA will continue post-marketing safety surveillance.
Saphris (asenapine) 3/12/2015 Web 03/05/2018 FDA will continue post-marketing safety surveillance.
Tivicay (dolutegravir) 08/12/2013 & 06/09/2016 Web 03/05/2018 FDA will continue post-marketing safety surveillance.
Trumenba Meningococcal Group B Vaccine 10/29/2014 Web 03/05/2018 FDA will continue post-marketing safety surveillance.
Dymista (azelastine hydrochloride fluticasone propionate) 2/20/2015 Web 01/07/2018 FDA will continue post-marketing safety surveillance.
Edurant (rilpivirine); Complera; and Odefsey 8/26/2015; 2/23/2016; 3/01/2016 Web 01/07/2018 FDA will continue post-marketing safety surveillance.
Merrem IV (meropenem) 12/19/2014 Web 01/07/2018 FDA will continue post-marketing safety surveillance.
Naftin (nafifine hydrochloride) 10/10/2014 & 11/11/2016 Web 01/07/2018 FDA will continue post-marketing safety surveillance.
OTIPRIO (ciprofloxacin otic suspension) 12/10/2015 Web 01/07/2018 FDA will continue post-marketing safety surveillance.
PAZEO (olopatadine hydrochloride ophthalmic solution) 01/30/2015 Web 01/07/2018 FDA will continue post-marketing safety surveillance.
QNASL beclomethasone dipropionate) nasal aerosol 12/17/2014 Web 01/07/2018 FDA will continue post-marketing safety surveillance.
Treximet (naproxen sodium sumatriptan succinate) 05/14/2015 Web 01/07/2018 FDA will continue post-marketing safety surveillance.
Valcyte (valganciclovir) 04/23/2015 Web 01/07/2018 FDA will continue post-marketing safety surveillance.
Keppra and Keppra XR (levetiracetam) 08/01/2014 Meeting 09/12/2017 September 12, 2017 - FDA did not identify any new safety signals, and plans to monitor for cardiovascular adverse events, rhabdomyolysis, and encephalopathy.
The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Aloxi (palonosetron hydrochloride) 05/27/2014 Web 08/04/2017 FDA will continue post-marketing safety surveillance.
Arnuity Ellipta (fluticasone furoate) 08/20/2014 Web 08/04/2017 FDA will continue post-marketing safety surveillance.
Asmanex HFA and Asmanex Twisthaler (mometasone furoate inhalation) 04/25/2014 Web 08/04/2017 FDA will continue post-marketing safety surveillance.
Cymbalta (duloxetine) 10/16/2014 Web 08/04/2017 FDA will continue post-marketing safety surveillance.
Emsam (selegiline transdermal system) 09/10/2014 Web 08/04/2017 FDA will continue post-marketing safety surveillance.
GRASTEK® Safety Review
GRASTEK® Utilization Review
(Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use
04/11/2014 Web 08/04/2017 FDA will continue post-marketing safety surveillance.
Latisse® (bimatoprost ophthalmic solution) 0.03% 09/04/2014 Web 08/04/2017 FDA will continue post-marketing safety surveillance.
Namenda and Namenda XR extended-release (memantine hydrochloride) 07/03/2014 Web 08/04/2017 FDA will continue post-marketing safety surveillance.
ORALAIR Safety Review
ORALAIR Utilization Review
(Sweet Vernal, Orchard Perennial rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for sublingual Use
04/01/2014 Web 08/04/2017 FDA will continue post-marketing safety surveillance.
Priftin® (rifapentine) 11/25/2014 Web 08/04/2017 FDA will continue post-marketing safety surveillance.
Reyataz® (atazanavir) 06/02/2014 & 09/24/2015 Web 08/04/2017 FDA will continue post-marketing safety surveillance.
Taclonex (betamethasone dipropionate/calcipotriene hydrate) 0.064%/0.005% 08/29/2014 & 12/23/2014 Web 08/04/2017 FDA will continue post-marketing safety surveillance.
Zetonna (ciclesonide) 10/23/2014 Web 08/04/2017 FDA will continue post-marketing safety surveillance.
Abilify (aripiprazole) 06/09/2014 Meeting 09/12/2017 September 12, 2017 - The PAC discussed the limitations of adverse event data collected in regards to rates of suicidality, serious metabolic disorders, and weight gain. One PAC members noted that some pediatric patients with autism may not be able to communicated about suicidal ideation.
The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Contegra Pulmonary Valved Conduit, mandated annual review 04/25/2013 Meeting 09/12/2017 September 12, 2017 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2018.
Enterra Therapy System, mandated annual review 03/25/2013 Meeting 09/12/2017 September 12, 2017 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2018.
Pleximmune, mandated annual review 08/26/2014 Meeting 09/12/2017 September 12, 2017 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2018.
Elana Surgical Kit (HUD), mandated annual review 03/10/2011 Meeting 09/12/2017 September 12, 2017 - FDA reported that there was no reported use, or new publications in the last year. The post approval study has been put on hold due to non-use in the United States, and would resume if there are any reported sales and use. The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2018.
Salonpas Relief(methyl salicylate 10% and 1-menthol 3%P Patch) 03/29/2013 Web 09/12/2016 FDA will continue post-marketing safety surveillance.
Nitropress (sodium nitroprusside) 11/22/2013 Meeting 03/06/2017 March 6, 2017- The Committee discussed the issue of elevated carboxyhemoglobin levels noted in some patients receiving Nitropress and voted that there was insufficient data available at this time to make a labeling change. The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Kuvan (sapropterin dihydrochloride) 04/23/2014 Meeting 03/07/2017 March 7, 2017- The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Novoeight® (turotocog alfa) Antihemophilic Factor (Recombinant) 10/15/2013 Meeting 03/07/2017 March 7, 2017- The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
RIXIBUS Coagulation Factor IX (Recombinant) 04/01/2014 Meeting 03/07/2017 March 7, 2017 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Medtronic Activa® Dystonia Therapy, mandated annual review 01/16/2013 Meeting 03/07/2017 March 7, 2017- The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, and MDR review to the PAC in 2018.
Impella RP System, mandated annual review 01/23/2015 Meeting 03/07/2017 March 7, 2017- The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, and MDR review to the PAC in 2018.
Liposorber LA-15 System, mandated annual review 10/10/2013 Meeting 03/07/2017 March 7, 2017- The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, and MDR review to the PAC in 2018.
Epicel (cultured epidermal autografts), initial review 10/25/2007 Meeting 03/07/2017 March 7, 2017- The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, and MDR review to the PAC in 2018.
Aleve PM® (naproxen sodium 220 mg and diphenhydramine hydrochloride 25 mg) 01/17/2014 Web 02/03/2017 FDA will continue post-marketing safety surveillance.
Astepro (azelastine hydrochloride) 08/30/2013 & 02/20/2015 Web 02/03/2017 FDA will continue post-marketing safety surveillance.
Jetrea® (ocriplasmin) Intravitreal Injection 06/13/2014 Web 02/03/2017 FDA will continue post-marketing safety surveillance.
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets, for oral use) 03/28/2013 Web 02/03/2017 FDA will continue post-marketing safety surveillance.
Spectazole (econazole nitrate) cream, 1%
Ecoza (econazole nitrate) topical foam, 1%
10/24/2013 Web 02/03/2017 FDA will continue post-marketing safety surveillance.
Truvada® (emtricitabine and tenofovir disoproxil fumarate) 07/08/2011 Web 02/03/2017 FDA will continue post-marketing safety surveillance.
Xerese® (5% acyclovir and 1% hydrocortisone cream) 01/22/2014 Web 02/03/2017 FDA will continue post-marketing safety surveillance.
Lysteda (tranexamic acid) 08/21/2013 Web 09/12/2016 FDA will continue post-marketing safety surveillance.
Baraclude (entecavir) 03/20/2014 Web 09/12/2016 FDA will continue post-marketing safety surveillance.
Isentress (raltegravir potassium) 12/20/2013 Web 09/12/2016 FDA will continue post-marketing safety surveillance.
MENVEO (Meningococcal Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) 08/01/2013 Meeting 09/14/2016 September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
IXIARO (Japanese Encephalitis Vaccine) 05/17/2013 Meeting 09/14/2016 September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Sustiva (efavirenz) 05/02/2013 Meeting 09/14/2016 September 14, 2016 - The Committee discussed the role of therapeutic drug levels, the risks to rapid metabolizers, how genomic testing would be useful, and the importance of adding this information to the label. The Committee welcomed a future discussion and review of these general issues.
The Committee concurred with the FDA proposal to considering adding the term catatonia to labeling; voted against the FDA to return with drug levels and genetic variations in the labeling, and concurred with the FDA proposal to continue post-marketing safety surveillance.
Topamax (topiramate) 03/28/2014 Meeting 09/14/2016 September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Asacol & Asacol HD(mesalamine) 10/08/2013 & 05/27/2015 Meeting 09/14/2016 September 14, 2016 - The Committee voted againstthe FDA recommendation to not change the label regarding benign intracranial hypertension. They requested that FDA further review this possible association, and concurred with the FDA recommendation to add nephrogenic diabetes insipidus to the list of adverse reactions that have been reported in the post -marketing section of product labeling for mesalamine products.
Delzicol (mesalamine) 04/28/2014 & 09/09/2015 Meeting 09/14/2016 September 14, 2016 - The Committee voted against the FDA recommendation to not change the label regarding benign intracranial hypertension. They requested that FDA further review this possible association, and concurred with the FDA recommendation to add nephrogenic diabetes insipidus to the list of adverse reactions that have been reported in the post -marketing section of product labeling for mesalamine products.
Kepivance (palifermin) 05/13/2013 Meeting 09/14/2016
September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Bloxiverz (neostigmine methylsufate) 05/31/2013 Meeting 09/14/2016 September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Doryx (doxycycline hyclate) 04/11/2013 Meeting 09/14/2016 September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Xolair (omalizumab) 03/21/2014 Meeting 09/14/2016 September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Karbinal ER (carbinoxamine maleate) 03/23/2013 Meeting 09/14/2016 September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD), mandated annual review 02/16/2011 Meeting 09/14/2016 September 14, 2016 - The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, MDR review to the PAC in 2017.
Contegra Pulmonary Valved Conduit, mandated annual review 04/25/2013 Meeting 09/14/2016 September 14, 2016 - The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, MDR review to the PAC in 2017.
Pleximmune, mandated annual review 08/26/2014 Meeting 09/14/2016 September 14, 2016 - The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, MDR review to the PAC in 2017.
Enterra™ Therapy System, mandated annual review 03/25/2013 Meeting 09/14/2016 September 14, 2016 - The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, MDR review to the PAC in 2017.
Elana Surgical Kit (HUD), mandated annual review 03/10/2011 Meeting 09/14/2016 September 14, 2016 - The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, MDR review to the PAC in 2017.
Ditropan (oxbutynin) *02/28/2002 Meeting 11/16/2006 November 16, 2006 (review update for QT Prolongation with Celexa and Lexapro) - Recommend routine monitoring for AEs in all populations.
Ditropan (oxybutynin)17 *02/08/2002 Meeting 06/12/2003 June 12, 2003 - PS requested future review after additional marketing experience.
November 16, 2006 - Preliminary reassessment.
February 6, 2008 - revised label
Ditropan (oxybutynin)17 *02/08/2002 Meeting 04/11/2007 April 11, 2007 (Follow-up) - The PAC requested labeling to include additional information concerning post-marketing reports of hallucinations and agitated behavior in the pediatric population. They noted prescribers might wish to first try decreasing the dose before discontinuing, depending on the circumstances of the adverse event.
Lipitor (atorvastatin)18 *02/22/2002 Meeting 06/12/2003 June 12, 2003 - PS requested future review after additional marketing experience.
Lipitor (atorvastatin)18 *02/22/2002 Meeting 11/16/2006 November 16, 2006 (Follow-up) - Committee recommended return to routine monitoring for adverse events (AEs) in all populations.
Zocor (simvastatin)19 *02/22/2002 Meeting 06/12/2003 June 12, 2003 - PS requested future review after additional marketing experience.
Zocor (simvastatin)19 *02/22/2002 Meeting 11/16/2006 November 16, 2006 (Follow-up) - Pediatric Advisory Committee recommended return to routine monitoring for AEs in all populations.
Busulfex (busulfan)20 *03/12/2002 Meeting 10/29/2003 October 29, 2003 - PS recommended return to routine monitoring for AEs in all populations.
Zyrtec (cetirizine)21 *03/13/2002 Meeting 10/29/2003 October 29, 2003 - Committee recommended return to routine monitoring for AEs in all populations.
Cozaar (losartan)22 *03/20/2002 Meeting 10/29/2003 October 29, 2003 - Committee recommended return to routine monitoring for AEs in all populations.
Nolvadex (tamoxifen)23 *05/16/2002 Meeting 10/29/2003 October 29, 2003 - Committee recommended return to routine monitoring for AEs in all populations.
Accupril (quinapril)24 *06/07/2002 Meeting 10/29/2003 October 29, 2003 - Committee recommended return to routine monitoring for AEs in all populations.
Serzone (nefazodone)25 *06/27/2002 Meeting 10/29/2003 October 29, 2003 - For additional information regarding PS recommendations and outcomes for SSRIs see Zoloft (sertraline HCl).
Paxil (paroxetine)26 *06/27/2002 Meeting 02/03/2004 February 2, 2004 - For additional information regarding PS recommendations and outcomes for SSRIs see Zoloft (sertraline HCl);
February 3, 2004 - PS agreed to future update on SSRIs, neonatal withdrawal, and eye malformation;
June 9, 2004 - PS endorsed class labeling for neonatal toxicity/withdrawal syndrome.
Pravachol (pravastatin)27 *07/10/2002 Meeting 02/03/2004 February 3, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Celexa (citalopram)28 *07/12/2002 Meeting 02/03/2004 February 2, 2004 - For additional information regarding PS recommendations and outcomes for SSRIs see Zoloft (sertraline HCl);
February 3, 2004
- PS agreed to future update on SSRIs, neonatal withdrawal, and eye malformation; PS requested update on QTc prolongation following future review of additional marketing experience;
June 9, 2004 - PS endorsed class labeling for neonatal toxicity/withdrawal syndrome;
February 18, 200 - label revised
Celexa (citalopram)28 *07/12/2002 Meeting 11/16/2006 November 16, 2006 (Follow-up) - PAC requested to receive/hear the results of the division's review of the company's QTc analysis, which they thought would be more useful than additional reviews of Adverse Events Reporting System (AERS).
Navelbine (vinorelbine)29 *08/15/2002 Meeting 02/03/2004 February 3, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Hycamtin (topotecan)30 *11/20/2002 Meeting 06/09/2004 June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Temodar (temozolomide)31 *11/20/2002 Meeting 06/09/2004 June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Effexor (venlafaxine)32 *12/02/2002 Meeting 06/09/2004 February 2, 2004 - For information regarding PS recommendations and outcomes for SSRIs see Zoloft (sertraline HCl);
June 9, 2004 - PS endorsed class labeling for neonatal toxicity/withdrawal syndrome.
February 18, 2005 - label revised
Vigamox (moxifloxacin)33 *01/10/2003 Meeting 06/09/2004 June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Ciloxan (ciprofloxacin)34 *01/10/2003 Meeting 06/09/2004 June 9, 2004 - Committee recommended return to routine monitoring for AEs in all populations.
Monopril (fosinopril)35 *01/27/2003 Meeting 06/09/2004 June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Allegra (fexofenadine)36 *01/27/2003 Meeting 06/09/2004 June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Duragesic (fentanyl)37 *01/29/2003 Meeting 06/09/2004 June 9, 2004 - PS strongly recommends that the "black box" section contain additional language indicating that: "inappropriate use may result in serious adverse effects including death" and highlight the need for qualifications of those prescribing the medication. Label updated February 2005, with black box warning and statement concerning use only in opioid tolerant patient.
February 7, 2008 - Revised label38
View Duragesic MedGuide39
Pulmicort/Rhinocort (budesonide)40 *11/12/2002 Meeting 09/15/2004 September 15, 2004 - Committee agreed with the Division of Pulmonary and Allergy Drug Products proposed label changes and recommended that a MedGuide be provided for pediatric family caregivers with respect to the new labeling for Salmeterol and Advair label changes;
July 20, 2006 - MedGuide approved
Clarinex (desloratadine)41 *02/12/2003 Meeting 09/15/2004 September 15, 2004 - Committee recommended return to routine monitoring for AEs in all populations.
Cutivate/Flonase/Flovent (fluticasone),42
Advair (fluticasone and salmeterol)43
*02/25/2003 Meeting 09/15/2004 September 15, 2004 - Committee recommendation that a MedGuide be provided for pediatric family caregivers with respect to the new labeling for Salmeterol and Advair label changes;
March 2, 2006 - MedGuide approved
Ocuflox (ofloxacin)44 *03/12/2003 Meeting 09/15/2004 September 15, 2004 - Committee recommended return to routine monitoring for AEs in all populations.
Fludara (fludarabine)45 *04/03/2003 Meeting 09/15/2004 September 15, 2004 - Committee recommended return to routine monitoring for AEs in all populations.
Fosamax (alendronate)46 *04/28/2003 Meeting 09/15/2004 September 15, 2004 - Committee recommended return to routine monitoring for AEs in all populations.
Lotensin (benazepril)47 *07/02/2003 Meeting 02/14/2005 February 14, 2005 - Committee recommended continued close monitoring of benazepril in the pediatric population for future review.
Lotensin (benazepril)47 *07/02/2003 Meeting 03/25/2008 March 25, 2008 (Follow-up) - Committee recommended return to routine monitoring for AEs in all population
Malarone (atovaquone/proguanil)48 *08/06/2003 Meeting 02/14/2005 February 14, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Brevibloc (esmolol)49 *08/22/2003 Meeting 02/14/2005 February 14, 2005 - Committee recommended to continue monitoring and provide future review.
Brevibloc (esmolol)49 *08/22/2003 Meeting 03/25/2008 March 25, 2008 (Follow-up) - Committee recommended return to routine monitoring for AEs in all populations.
Viracept (nelfinavir)50 *09/04/2003 Meeting 02/14/2005 February 14, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Xenical (orlistat)51 *09/12/2003 Meeting 02/14/2005 February 14, 2005 - Committee recommended continued monitoring and future review for the risk of cholelithiasis;
Xenical (orlistat)51 *09/12/2003 Meeting 04/11/2007 April 11, 2007 (Follow-up) - Committee recommended return to routine monitoring for AEs in all populations.
Glucovance (glyburide/metformin)52 *10/08/2003 Meeting 02/14/2005 February 14, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Arava (leflunomide)53 *11/10/2003 Meeting 06/30/2005 June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Concerta (methylphenidate)54 *12/04/2003 Meeting 06/30/2005 June 30, 2005 - Committee was informed of ongoing collaborative study between Duke University, NICHD, and NIH to assess methylphenidate clastogenic potential in children. Committee was updated on efforts to look into psychiatric behavior and cardiovascular for all therapies used for ADHD. The committee agreed to delay making labeling recommendations until the division had completed their examinations of adverse event reports in all stimulant products with respect to psychiatric and cardiovascular risk adverse events.
February 21, 2007 - FDA directs ADHD drug manufacturers to notify patients about cardiovascular adverse events and psychiatric adverse events. See MedGuide and label55
For additional information on ADHD products see Aderall XR March 22, 2006 meeting.
June 27, 2008 - revised label
Zemplar (paricalcitol)56 *12/08/2003 Meeting 06/30/2005 June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Zomig (zolmitriptan)57 *12/18/2003 Meeting 06/30/2005 June 30, 2005 -Committee recommended return to routine monitoring for AEs in all populations.
Ortho-Tri-Cyclen (ethinyl estradiol; norgestimate)58 *12/18/2003 Meeting 06/30/2005 June 30, 2005 -Committee recommended return to routine monitoring for AEs in all populations.
Cipro (ciprofloxacin)59 *12/18/2003 Meeting 06/30/2005 June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Trusopt (dorzolamide)60 *01/05/2004 Meeting 06/30/2005 June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Detrol;Detrol LA (tolterodine)61 *01/05/2004 Meeting 06/30/2005 June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Agrylin (anagrelide)62 *05/24/2004 Meeting 11/18/2005 November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Paraplatin (carboplatin)63 *04/30/2004 Meeting 11/18/2005 November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Diflucan (fluconazole)64 *01/21/2004 Meeting 11/18/2005 November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Camptosar (irinotecan)65 *03/10/2004 Meeting 11/18/2005 November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Tamiflu (oseltamivir phosphate)66 *03/22/2004 Meeting 11/18/2005 November 18, 2005 - PAC requested follow-up within 2 years on neuropsychiatric (NP) and behavioral events.
Labeling67.
January 17, 2008 - revised label.
Tamiflu (oseltamivir phosphate)66 *03/22/2004 Meeting 11/16/2006 November 16, 2006 (Follow-up) - the Committee concurred with previous PAC request for an extensive analysis including (1) a report by the sponsor on NP events; (2) requested FDA invite Japanese experts to report on their experience and ask for Japanese data on the extent of prophylactic use and AEs in said population;
Tamiflu (oseltamivir phosphate)66 *03/22/2004 Meeting 11/28/2007 November 28, 2007 (Follow-up) - Committee recommended FDA continue to monitor AEs for Tamiflu on a monthly basis and recommended labeling changes to include: a description of NP symptoms which may occur due to the influenza illness, irrespective of drug therapy; to convey uncertainty in causality of the NP symptoms; to note abrupt appearance of symptoms; and to indicate that "injurious behavior" included fatal outcomes. Similar labeling changes were recommended for the other antiviral influenza medications.
Vioxx (rofecoxib)68 *02/18/2004 Meeting 11/18/2005 November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Ferrlecit (sodium ferric gluconate complex in sucrose injection)69 *03/24/2004 Meeting 11/18/2005 November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Imitrex (sumatriptan)70 02/18/2004 Meeting 11/18/2005 November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Avapro (irbesartan)71 *09/16/2004 Meeting 03/22/2006 March 22, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Clolar (clofarabine)72 *03/30/2004 Meeting 03/22/2006 March 22, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Adderall XR (dextroamphetamine saccharate, amphetamine aspirate monohydrate, dextroamphetamine sulfate, amphetamine sulfate)73 *10/28/2004 Meeting 03/22/2006 March 22, 2006 - It was noted that ADHD medications have been shown to be effective in children properly diagnosed with ADHD. The Commitee addressed the adverse events individually: Psychosis/Mania (including hallucinations) -- Labeling for psychosis was warranted and could be further clarified; Stated that it was important to enhance the current warnings in the label regarding psychosis, mania and hallucinations; Aggression -- Parents need to contact physician if new (treatment emergent) aggression occurs or if symptoms of aggression worsen during therapy; Cardiovascular -- Did not request box warning. Committee did request strong warnings recommended MedGuide or information sheet for patients with underlying structural cardiovascular defects or cardiomyopathies;
February 21, 2007 - FDA directs ADHD drug manufacturers to notify patients about cardiovascular adverse events and psychiatric adverse events. See MedGuide and label74.
May 22, 2007 - revised label
Meridia (sibutramine hydrochloride monohydrate)75 *10/06/2004 Meeting 03/22/2006 March 22, 2006 - Committee recommended continued monitoring and requested an update on sibutramine adverse events after completion of the Subutramine Cardiovascular Outcomes (SCOUT) Study.
Rapamune (sirolimus)76 *11/17/2004 Meeting 11/16/2006 November 16, 2006 - Committee requested to be informed (email was adequate) about the outcome of discussions with the Sponsor about potential labeling changes concerning pericarditis.
October 17, 2007 - adverse reactions section of label modified to include information on pericardial effusion see label77
Zofran (ondansetron)78 *12/01/2004 Meeting 11/16/2006 November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Avandia (rosiglitazone)79 *12/09/2004 Meeting 11/16/2006 November 16, 2006 - Committee recommended that a statement regarding lack of efficacy should also be placed in the pediatric patient information part of the label. The committee noted the current statement is not helpful.
Gemzar (gemcitabine)80 *01/27/2005 Meeting 11/16/2006 November 16, 2006 Committee recommended return to routine monitoring for AEs in all population- s.
Invanz (ertapenem)81 *02/11/2005 Meeting 11/16/2006 November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Zyvox (linezolid)82 *02/11/2005 Meeting 11/16/2006 November 16, 2006 - pending completion of the ongoing review of cardiac events for all age populations by the Office of Surveillance and Epidemiology, the committee requested a report.
Zyvox (linezolid)82 *02/11/2005 Meeting 11/18/2008 November 18, 2008 (Follow-up) - Committee accepted the follow-up report that revealed no new safety signals, but requested to see the completed QT report.
Trileptal (oxcabazepine)83 *03/02/2005 Meeting 11/16/2006 November 16, 2006 The Committee made no recommendation at this time contingent on hearing the division's independent analysis of the suicidality events; in particular they would like a subpopulation analysis focusing on pediatrics (over 2,000 patients) to be provided whenever the division has completed their review.
Trileptal (oxcabazepine)83 *03/02/2005 Meeting 03/25/2008 March 25, 2008 (Follow-up) - Preliminary review of pediatric subpopulation. Further evaluation of entire of adult and pediatric populations pending.
Mobic (meloxicam)84 *04/15/2005 Meeting 11/16/2006 November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Novolog (insulin aspart recombinant)85 *05/24/2005 Meeting 11/16/2006 November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Amaryl (glimepiride)86 *06/09/2005 Meeting 11/16/2006 November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Norvir (ritonavir)87 *06/14/2005 Meeting 11/16/2006 November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Lescol (fluvastatin)88 *12/15/2005 Meeting 04/11/2007 April 11, 2007 - Committee recommended routine monitoring for AEs in all populations.
Sandostatin (octreotide)89 *01/12/2006 Meeting 04/11/2007 April 11, 2007 - Committee did not believe a causal link was established for necrotizing enterocolitis (NEC) or hypoxia. Because of the increased use of this product in a population at risk for NEC and hypoxia, most members recommended that information on these AEs in this high risk population be placed in the label. Recommended 1 year update focused on observed post marketing adverse events of NEC and hypoxia. Committee members inquired about the need for additional studies, including registries and/or availability of well-controlled trials.
January 25, 2010 - revised label.
Sandostatin (octreotide)89 *01/12/2006 Meeting 11/18/2008 November 18, 2008 (Follow-up)- Committee agreed with FDA recommendation to harmonize the LAR and Injection Solution versions of the label. Committee recommended that FDA include in the label information about serious pediatric AEs and acknowledge no causal association has been established. Committee recommended that FDA work with NIH regarding a systematic review of actual use and AEs from off-label use. Committee recommended that FDA continue its standard, ongoing safety monitoring.
Serevent (salmeterol)90 *03/09/2006 Meeting 11/28/2007 November 28, 2007 - Committee recommended more extensive discussion of benefit/risk of salmeterol with pediatric use and requested a report back to the Committee after additional review of existing data. They recommended labeling changes to include: specifically identifying risks of deaths and increased hospitalizations as potential pediatric adverse risks; updated “Pediatric Use” section with additional safety information; and to provide some quantification of risks. The committee also recommended reorganization of the MedGuide to more prominently display the safety information and straightforwardly present that salmeterol should not be used as monotherapy. Labeling should also reflect the lack of certainty that corticosteroids mitigate serious adverse events.
December 10-11, 2008 - A joint meeting of FDA’s Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and Pediatric Advisory Committee met to discuss the risks/benefits of LABA medications after FDA further analysis and recommended removal of asthma indication91.
Provigil (modafinil)92 *03/21/2006 Meeting 11/28/2007 November 28, 2007 - Committee recommended that the label include the ADHD pediatric clinical trial data and that it include stronger language that it is not approved for any pediatric indication because of safety issues. This information is also to be placed in the PPI part of the label.
October 21, 2010 - Label change
Emtriva (emtricitabine)93 *05/24/2006 Meeting 11/28/2007 November 28, 2007 - Committee recommended return to routine monitoring for AEs in all populations.
Gleevec (imatinib mesylate)94 *06/09/2006 Meeting 11/28/2007 November 28, 2007 - Committee recommended return to routine monitoring for AEs in all populations.
Azopt (Brinzolamide)95 *06/28/2006 Meeting 11/28/2007 November 28, 2007 - Committee recommended return to routine monitoring for AEs in all populations.
Betaxon (levobetaxolol)96 *06/28/2006 Meeting 11/28/2007 November 28, 2007 - No recommendations. This drug is not marketed.
Toprol XL (metoprolol)97 *07/27/2006 Meeting 03/25/2008 March 25, 2008- Committee recommended return to routine monitoring for AEs in all populations.
Celebrex (celecoxib)98 *08/23/2006 Meeting 03/25/2008 March 25, 2008 - Committee agreed with the FDA recommendation to have a follow up once data from the postmarketing safety studies have been analyzed.
Colazal (balsalazide)99 *08/23/2006 Meeting 03/25/2008 March 25, 2008 - Committee agreed to be updated by email once the labeling change currently being reviewed by the FDA to add postmarking AEs seen in other 5-ASA products in the pediatric population was approved. Committee requested additional information before making a recommendation on monitoring for AEs.
Suprane (desflurane)100 *09/13/2006 Meeting 03/25/2008 March 25, 2008 - Committee agreed with the FDA proposal to add the adverse event “cardiac arrest” to the labeling. Some members of the committee recommended further restricting the use of this product in pediatrics in the labeling. Others deferred until additional information from pediatric anesthesiologists is provided. Committee recommended continued pediatric focused monitoring.
April 14, 2009 - revised label.
September 2013, Revised Label
Suprane (desflurane)100 *09/13/2006 Meeting 06/21/2010 June 21, 2010 (Follow-up) - Committee discussed the importance of enhanced anesthesiology education and training when using this product; the safety issue with using this product in non-intubated patients; and the most common respiratory side effects as laryngospasm, cough, and increased secretions. Committee asked for more prominent labeling for pediatric use to address the need for enhanced warnings for pediatric patients. Committee agreed that the present label does not adequately represent the risks and benefits of this product for its intended use. Committee recommends strengthening the labeling and the use of maintenance in non-intubated pediatric patients be contraindicated.
Eloxatin (oxaliplatin)102 *09/27/2006 Meeting 03/25/2008 March 25, 2008 - Committee recommended return to routine monitoring for AEs in all populations.
Coreg (carvedilol)103 *11/08/2006 Meeting 03/25/2008 March 25, 2008 - Committee agreed with the FDA recommendation that the labeling be revised to include information on hypoglycemia similar to the text in the propranolol labeling. The Advisory Committee recommended FDA consider adding additional information in labeling regarding PK and the dose which resulted in the inadequate exposure during the trial. Committee recommended return to routine monitoring for AEs in all populations.
Ambien (zolpidem)104 *11/20/2006 Meeting 11/18/2008 November 18, 2008 - Committee recommended that FDA continue its standard, ongoing safety monitoring.
Lamisil (terbinafine)105 *12/04/2006 Meeting 11/18/2008 November 18, 2008 - Committee recommended that FDA continue its standard, ongoing safety monitoring.
Aldara (imiquimod)106 *12/13/2006 Meeting 11/18/2008 November 18, 2008 - Committee requested that text about the negative studies in children as well as local skin reactions in the genital area leading to “inability to urinate” be added to the label. Committee requested that FDA consider including a statement in the Patient Information section that imiquimod was not shown to be effective in children less than 12 years. Committee recommended that FDA continue its standard, ongoing safety monitoring.
Oct. 13, 2010 - Labeling change.
Zyprexa (olanzapine)107 *01/10/2007 Meeting 11/18/2008 November 18, 2008 - Committee requested: (1) additional information regarding pediatric use in this class of products, (2) studies of long-term adverse effects in pediatrics (e.g., metabolic AEs) (3) additional information on movement AEs, and (4) other requests108. The committee agreed with the labeling change proposed by the Division. The labeling was changed January 27, 2010.
June 21, 2011 - revised label109
Lamictal (lamotrigine)110 *02/14/2007 Meeting 11/18/2008 November 18, 2008 - Committee supported recommendation made at the July, 2008 AC regarding labeling about suicidality. Committee recommended that FDA continue its standard, ongoing safety monitoring.
May 5, 2009 - revised label111.
Risperdal (risperidone)112 *02/28/2007 Meeting 11/18/2008 November 18, 2008 - Committee requested: (1) additional information regarding pediatric use in this class of products, (2) studies of long-term adverse effects in pediatrics (e.g., metabolic AEs) (3) additional information on movement AEs, and (4) other requests113101. The committee agreed with the labeling change proposed by the Division. The labeling was changed August 30, 2010.
March 12, 2012 - Revised Label
Betoptic S (betaxolol)114 *02/28/2007 Meeting 11/18/2008 November 18, 2008 - Committee recommended that FDA return to routine monitoring for AEs
Timolol GFS (timolol)115 *02/28/2007 Meeting 11/18/2008 November 18, 2008 - Committee recommended that FDA return to routine monitoring for AEs
Levaquin (levofloxacin)116 *03/14/2007 Meeting 11/18/2008 November 18, 2008 - Committee recommended that FDA revise the label to include text about other drug products known to cause prolonged QT interval. FDA to continue its standard, ongoing safety monitoring.
Combigan (brimonidine/timolol)117 10/30/2007 Meeting 06/23/2009 June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Derma-Smoothe/FS (fluocinolone acetonide)118 12/12/2007 Meeting 06/23/2009 June 23, 2009 Recommended that the FDA consider modifying label to reflect there had been actual cases of peanut allergic reactions and that it was not just a hypothetical concern.
Hepsera (adefovir dipivoxil)119 12/19/2007 Meeting 06/23/2009 June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Inspra (eplerenone)120 01/31/2008 Meeting 06/23/2009 June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Moxatag (amoxicillin)121 01/23/2008 Meeting 06/23/2009 June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Alvesco (ciclesonide)122 01/10/2008 Meeting 06/23/2009 June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Omnaris (ciclesonide)123 11/21/2007 Meeting 06/23/2009 June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs
Zometa (zoledronic acid)124 03/20/2008 Meeting 06/23/2009 June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Diovan (valsartan)125 11/29/2007 Meeting 06/23/2009 June 23, 2009 Committee recommended FDA revise labeling to put additional emphasis on the potential for development of pulmonary hypoplasia. Committee recommended that FDA return to routine monitoring for AEs.
Asmanex (mometasone furoate)126 02/01/2008 Meeting 06/23/2009 June 23, 2009 Committee recommended labeling be revised to clearly state that lactose is an ingredient in the excipient powder and recommended to harmonize the labeling for all dry product inhalers. Committee recommended that FDA return to routine monitoring for AEs.
Sept. 17, 2010 - Labeling changed.
AndroGel (testosterone)127 12/27/2007 Meeting 06/23/2009 June 23, 2009 Committee recommended FDA examine the effects of low level secondary exposure and encourage studies of the transfer of drug product from inanimate objects to people. The Committee also provided specific labeling recommendations including (1) revising text using descriptive, easy to understand language, (2) defining the term “virilization” for the consumer, (3) adding information on the pediatric studies performed and the risks, other than just bone effects, of secondary exposure to Section 8.4 Pediatric Use, and (4) revising the illustration in Section 17.3 FDA-Approved patient Labeling to be consistent with application instructions. The Committee recommended measures be taken immediately to reduce risk of exposure, including changing skin application sites and limiting use in families with children.
September 18, 2009, revised label128
Depakote (divalproex sodium)129 03/24/2008 Meeting 06/23/2009 June 23, 2009 Committee agreed to FDA continuing its review and analysis of neurodevelopmental delay associated with fetal exposure to Depakote (divalproex sodium). If any additional safety signal emerges or a pediatric labeling change is made, a report to the Committee will be provided.
December 7, 2010 - Committee updated with the analysis on the neurodevelopment delay information.
Zetia/Vytorin (ezetimibe/simvastatin)130 06/05/2008 Meeting 12/08/2009 December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Aptivus (tipranavir)131 06/23/2008 Meeting 12/08/2009 December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Reyataz (atazanavir Sulfate)132 03/25/2008 Meeting 12/08/2009 December 8, 2009 Committee recommended that FDA encourage the sponsor to increase its effort to submit more data in order to obtain dosing information for the age group 3 months to 6 years. Committee recommended return to standard, ongoing, monitoring for adverse events.
Kaletra (topinavir/ritonavir)133 11/09/2007 & 06/20/2008 Meeting 12/08/2009 December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
September 22, 2011 - Committee was given an informational update.
December 2011,revised label134
Argatroban (argatroban)135 05/05/2008 Meeting 12/08/2009 December 8, 2009 Committee requested that FDA encourage sponsor to study and report more information on dosing this product for pediatric patients with HIT. Committee recommended return to standard, ongoing monitoring for adverse events.
Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection)136 12/27/2007 Meeting 12/08/2009 December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Evicel [fibrin sealant (human)]137 01/02/2008 Meeting 12/08/2009 December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Artiss [fibrin sealant (human)]138 03/19/2008 Meeting 12/08/2009 December 8, 2009 Committee recommended that FDA consider revising the label to include information on specific ages of those studied in the pre-market clinical trials. Committee discussed the use of this product in very young children with burns. And recommended that its use be studied in children less than 1 year. Committee recommended return to standard, ongoing monitoring for adverse events.
Cancidas (caspofungin)139 07/29/2008 Meeting 12/08/2009 December 8, 2009 Committee agreed that FDA: 1) update the labeling to clarify the hepatobiliary events that have been reported in pediatric and adult patients; 2) conduct a study in infants who were less than 3 months of age who had fungal infections and needed this therapy; 3) return to standard, ongoing monitoring for adverse events. January 28, 2010, revised label140.
Ventolin HFA (albuterol)141 03/26/2008 Meeting 12/08/2009 December 8, 2009 Committee discussed route of drug administration (HFA and nebulizer) for children 0-4 years of age and discussed the safety risk from lack of efficacy for this product for children less than 4. Committee recommended that FDA return to ongoing safety monitoring, and recommended that the label be amended to include additional information including warnings for children 0-4 years of age.
Orencia (abatacept)142 04/07/2008 Meeting 12/08/2009 December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Humira (adalimumab)143 02/21/2008 Meeting 12/08/2009 December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Abilify (aripiprazole)144 10/29/2007 & 02/27/2008 Meeting 12/08/2009 December 8, 2009 Committee did not support that the labeling adequately reflects the possible risk of pediatric weight gain and recommends additional information on weight gain be added. The Committee requested that FDA review the use data on atypical antipsychotics for children with a diagnosis of ADHD. Committee recommended return to standard, ongoing monitoring for adverse events.
Lancome UV Expert; 40 La Roche-Posay; Anthelios 40 Vichy; Capital Soleil 40145 03/31/2008 Meeting 03/22/2010 March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Cardiolite (technetium Tc99m)146 04/30/2008 Meeting 03/22/2010 March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Nasacort AQ (triamcinolone)147 09/19/2008 Meeting 03/22/2010 March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Viramune (nevirapine)148 06/24/2008 Meeting 03/22/2010 March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Daptacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)149 03/12/2008 Meeting 03/22/2010 March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)150 06/24/2008 Meeting 03/22/2010 March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)151 06/20/2008 Meeting 03/22/2010 March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Rotarix (Rotavirus Vaccine, Live, Oral)152 04/03/2008 Meeting 03/22/2010 March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Valtrex (valacyclovir)153 09/03/2008 Meeting 03/22/2010 March 22, 2010 Committee agreed with FDA plan to update the labeling to clarify that central nervous system adverse reactions have been reported in pediatric and adult patients. Committee recommended return to standard, ongoing monitoring for adverse events.
Zmax (arithromycin)154 10/08/2008 Meeting 03/22/2010 March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Casodex (bicalutamide)155 12/19/2008 Meeting 03/22/2010 June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Apidra (insulin glulisine recombinant)156 10/24/2008 Meeting 06/21/2010 June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events and medication errors, including device failures associated with insulin delivery systems.
NovoLog (insulin aspart (rDNA))157 03/14/2008 Meeting 06/21/2010 June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events and medication errors, including device failures associated with insulin delivery systems.
Arimidex (anastrozole)158 12/05/2008 Meeting 06/21/2010 June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Desmopressin Acetate159 05/08/2008 Meeting 06/21/2010 June 21, 2010 Committee discussed the increased tablet use in conjunction with the removal of the nasal formulation. Committee recommended return to standard, ongoing monitoring for adverse events.
Prevacid (lansoprazole)160 10/28/2008 Meeting 06/21/2010 June 21, 2010 Committee discussed the need for additional data to evaluate treated symptoms, dosing schemes, and bone fractures issues related to Proton Pump Inhibitor (PPI) use. Committee requested updates after the upcoming Advisory Committee Meeting on PPIs and neonatal study endpoints. Based on the above they recommended return to standard, ongoing monitoring for adverse events.
Nexium (esomeprazole magnesium)161 02/27/2008 & 06/18/2009 Meeting 06/21/2010 June 21, 2010 Committee discussed the need for additional data to evaluate treated symptoms, dosing schemes, and bone fractures issues related to Proton Pump Inhibitor (PPI) use. Committee requested updates after the upcoming Advisory Committee Meeting on PPIs and neonatal study endpoints. Based on the above they recommended return to standard, ongoing monitoring for adverse events.
Aciphex (rabeprazole)162 06/30/2008 Meeting 06/21/2010 June 21, 2010 Committee discussed the need for additional data to evaluate treated symptoms, dosing schemes, and bone fractures issues related to Proton Pump Inhibitor (PPI) use. Committee requested updates after the upcoming Advisory Committee Meeting on PPIs and neonatal study endpoints. Based on the above they recommended return to standard, ongoing monitoring for adverse events.
Prilosec (omeprazole)163 03/20/2008 Meeting 06/21/2010 June 21, 2010 Committee discussed the need for additional data to evaluate treated symptoms, dosing schemes, and bone fractures issues related to Proton Pump Inhibitor (PPI) use. Committee requested updates after the upcoming Advisory Committee Meeting on PPIs and neonatal study endpoints. Based on the above they recommended return to standard, ongoing monitoring for adverse events.
OraVerse Injection (phentolamine mesylate)164 05/09/2008 Meeting 06/21/2010 June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Zemuron (rocuronium)165 08/28/2008 Meeting 06/21/2010 June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Kogenate FS (antihemophilic factor (recombinant))166 10/10/2008 Meeting 06/21/2010 June 21, 2010 Committee discussed the importance of developing databases to identify pediatric usage for products intended to treat rare diseases such as Kogenate FS. Committee recommended return to standard, ongoing monitoring for adverse events.
Acanya Gel (clindamycin/benzoyl peroxide combo)167 10/21/2008 Meeting 12/07/2010 December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Ulesfia Lotion 5% (benzl alcohol)168 04/09/2009 Meeting 12/07/2010 December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Epiduo Gel (adapalene & benzoyl peroxide)169 12/17/2008 Meeting 12/07/2010 December 7, 2010 Committee recommended to revise the label to include potential for patient hypersensitivity to the product and a follow-up after label revision. Feburary 18, 2011 - Revised Label
Gardasil [Human Papillomavirus Quadrivalent (types 6, 11, 16, 18) vaccine recombinant]170 09/12/2008 Meeting 12/07/2010 December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events. The committee also expressed the need for improved communication between physicians and their patients regarding the potential for syncope associated with the injection of the vaccine.
Xyzal (levocetirizine dihydrochloride)171 08/21/2009 Meeting 12/07/2010 December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events. The committee suggested that FDA should monitor and compare adverse events between Xyzal and Zyrtec, and other anti-histamines, to identify whether there are trends of neuropsychiatric adverse events.
Flovent HFA (fluticasone propionate)172 07/01/2008 Meeting 12/07/2010 December 7, 2010 Committee recommends adding dental caries and tooth discoloration to the post-marketing section of the label; advocate growth studies in children 0 to 4 years of age and revise the label to explain that the efficacy of the drug has not been established in patients <4 years of age.
Neulasta (pegfilgrastim)173 11/14/2008 Meeting 12/07/2010 December 7, 2010 Committee agreed to no labeling change; retain the pediatric PK information in the labeling; and to wait until FDA has completed its pediatric medication error review before adding information to the labeling.
Prezista (darunavir ethanolate)174 12/18/2008 Meeting 12/07/2010 December 7, 2010 Committee agreed to a follow-up after the following has taken place: review of AEs across the class of drugs; review autoimmune response in all HIV anti-viral products; review of immune reconstitution syndrome (IRS) literature of all populations with all autoimmune AEs.
PegIntron (peginterferon alfa-2b)175 12/11/2008 Meeting 12/07/2010 December 7, 2010 Committee agreed to a follow-up after the FDA considers the effect associated with use of product and liver transplant; complete class review; and labeling has been revised.
Axert (almotriptan)166176 04/30/2009 Meeting 12/07/2010 December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Lamictal XR (lamotrigine)177 05/29/2009 & 01/29/2010 Meeting 12/07/2010 December 7, 2010 Committee agreed to a follow-up after a labeling revision which includes lactation data from the literature and ongoing studies is completed.
Lamictal (lamotrigine) 05/08/2009 Meeting 12/07/2010 December 7, 2010 Committee agreed to a follow-up after a labeling revision which includes lactation data from the literature and ongoing studies is completed.
HIBERIX Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)178 08/19/2009 Meeting 05/16/2011 May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Bepreve (bepotastine besilate)179 09/08/2009 Meeting 05/16/2011 May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Besivance (besifloxacin)180 05/28/2009 Meeting 05/16/2011 May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Cetraxal (ciprofloxacin otic)181 05/01/2009 Meeting 05/16/2011 May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Patanase Spray (olopatadine hydrochloride)182 04/15/2008 & 12/01/2009 Meeting 05/16/2011 May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Astepro spray(azelastine hydrocholoride)183 08/31/2009 Meeting 05/16/2011 May 16, 2011 - Committee requested a focused use review on all pediatric adverse events since marketing (2009). Committee recommended return to standard, ongoing monitoring for adverse events.
Crestor (rosuvastatin)184 10/15/2009 Meeting 05/16/2011 May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Welchol (colesevelam)185 10/02/2009 Meeting 05/16/2011 May 16, 2011 - Committee discussed the new granular formulation and its impact on the 2 to 10 year old population. Requested a focused use review. Committee recommended return to standard, ongoing monitoring for adverse events.
Intuniv (guanfacine)186 09/02/2009 Meeting 05/16/2011 May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Lexapro (escitalopram oxalate)187 03/19/2009 Meeting 05/16/2011 May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Actonel (risedronate)188 07/23/2009 Meeting 05/16/2011 May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Valcyte (valganciclovir)189 08/28/2009 Meeting 05/16/2011 May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Retrovir (zidovudine)190 09/19/2008 & 11/06/2009 Meeting 09/22/2011 September 22, 2011 - Committee agreed with the FDA recommendation for dosing changes to reduce medication errors and recommended a follow-up after changes have been implemented. Revised labeling, 5/2012 191
Ziagen (abacavir)192 12/19/2008 Meeting 09/22/2011 September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Topamax (topiramate)193 12/22/2009 Meeting 09/22/2011 September 22, 2011 - Committee recommended labeling change to better define pediatric experience with adverse events of weight loss, bone mineralization, and particularly the life threatening nature of some episodes of epistaxis. They also strongly recommend that information from the adolescent migraine study be added to the label. Revised Label194, 3/2014
Navstel Intraocular Irrigating Solution Sterile (balanced salt ophthalmic solution with hypromellose, dextrose & glutathione)195 07/24/2008 Meeting 09/22/2011 September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Akten Ophthalmic (lidocaine hydrochloride ophthalmic gel 3.5%)196 10/07/2008 Meeting 09/22/2011 September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Triesence (trimcinolone acetonide injectable suspension)197 11/29/2007 Meeting 09/22/2011 September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Melody Transcatheter Pulmonary Valve and Ensemble Delivery System198, initial review 01/25/2010 Meeting 09/22/2011 September 22, 2011 - Committee agreed that the HDE device is appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
FLUARIX Influenza virus vaccine199 10/19/2009 Meeting 09/22/2011 September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
AFLURIA Infuenza virus vaccine200 11/10/2009 Meeting 09/22/2011 September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Famvir (famciclovir)201 12/24/2009 Meeting 09/22/2011 September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Videx EC (didanosine)202 09/29/2008 Meeting 09/22/2011 September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Abilify (aripiprazole)203 11/19/2009 Meeting 09/22/2011 September 22, 2011 - Committee recommended language to clarify the potential for metabolic and weight effects in the pediatric population and a follow-up 12-18 months after labeling change. February 22, 2012, revised label204
Zomig Nasal Spray(zolmitriptan)205 10/14/2008 Meeting 09/22/2011 September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Levaquin (levofloxacin)206 05/05/2008 Meeting 09/22/2011 September 22, 2011 - Committee recommended that information on anthrax emergency response be added to the indication and usage sections in the label. Committee recommended return to standard, ongoing monitoring for adverse events.
Focalin XR (dexmethylphenidate hydrochloride)207 12/23/2009 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. They also recommended revisions to the label to include; strengthening text regarding hallucinations, suicidality, and extrapyramidal symptoms. Committee agreed with FDA’s plan to add angioedema and anaphylaxis to the label. Committee requested a follow up presentation after a labeling revision and harmonizing the labels for all methylphenidate products are completed.
Daytrana (methylphenidate)208 12/14/2009 & 06/29/2010 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Seroquel (quetiapine fumarate)209 12/02/2009 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Xolair (omalizumab)210 01/04/2010 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. PAC discussed adding an informational website link to the package insert.
Plan B One-Step (levonorgestrel)211 07/10/2009 Meeting 01/30/2012 January 30, 2012 Committee recommended return to standard, ongoing monitoring for adverse events.
Flomax (tamsulosin hydrochloride)212 12/22/2009 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Atacand (candesartan cilexetil)213 10/22/2009 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee wanted a follow up when all the ACE inhibitor products were harmonized with regards to the pregnancy labeling.
Benicar (olmesartan medoxomil)214 02/04/2010 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee wanted a follow up when all the ACE inhibitor products were harmonized with regards to the pregnancy labeling.
February 15, 2012, label revised215.
Pancreaze (pancrelipase)216 04/12/2010 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. It was suggested to FDA that more information be added to the label dosing instructions regarding the volume amount to be used with the product.
Zenpep (pancrelipase)217 08/27/2009 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. It was suggested to FDA that more information be added to the label dosing instructions regarding the volume amount to be used with the product.
Creon (pancrelipase)218 04/30/2009 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. It was suggested to FDA that more information be added to the label dosing instructions regarding the volume amount to be used with the product.
Xerese (acyclovir/hydrocortisone)219 07/31/2009 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Mirena (levonorgestrel releasing intrauterine system)220 10/01/2009 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Prevnar 13 [pneumococcal 13-valent conjugate vaccine (diptheria CRM197 protein)]221 02/24/2010 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee raised questions about a possible safety signal related to the SIDS cases.
Cervarix (human papilloma virus bivalent (types 16 & 18) vaccine recombinant)222 10/16/2009 & 07/19/2011 Meeting 01/30/2012 January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Tamiflu (oseltamivir phosphate)223 02/22/2010 Meeting 05/07/2012 May 7, 2012- Committee commended FDA on its extensive safety review of this product over the last decade and recommended return to standard, ongoing monitoring for adverse events.
Viread (tenofovir disoproxil fumate)224 03/24/2010 Meeting 05/07/2012 May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Differin (adapalene)225 03/17/2010 Meeting 05/07/2012 May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee requested an update after the review is completed.
MultiHance (gadobenate dimeglumine)226 03/17/2010 Meeting 05/07/2012 May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Dulera (formoterol fumarate; mometasone furoate)227 06/22/2010 Meeting 05/07/2012 May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events in the 5 - 11 year olds. Committee discussed safety issues in the < 5 year old age group and need for additional clarity in labeling concerning not using this product in under 5 year olds. Committee recommended more information be added to the label regarding aggressive behavior and neuropsychiatric events in the < 5 year olds. The Committee discussed additional ways to inform providers/caretakers concerning this issue. The Committee requested follow-up on labeling changes, adverse events and an update after trials for the 5/2011 year olds are completed.
Nasonex (mometasone furoate monohydrate)228 05/26/2010 & 01/19/2011 Meeting 05/07/2012 May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Taxotere (docetaxel)229 05/13/2010 Meeting 05/07/2012 May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Omnaris (ciclesonide)230 05/07/2010 Meeting 05/07/2012 May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Natazia (dienogest; estradiol valerate)231 05/06/2010 Meeting 05/07/2012 May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Protonix (pantoprazole sodium)232 11/12/2009 Meeting 05/07/2012 May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
MENVEO Meningococcal (Groups A,C,Y and W/20135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine233 02/19/2010 & 01/28/2011 Meeting 05/07/2012 May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine Recombinant234 10/16/2009 & 12/22/2010 Meeting 05/07/2012 May 7, 2010 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee also expressed the need for improved communication between physicians and their patients regarding the potential for syncope associated with the injection of the vaccine.
Zymaxid (gatifloxacin)235 05/18/2010 Meeting 05/07/2012 May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Zylet (loteprednol etabonate and tibramycin)236 06/03/2010 Meeting 05/07/2012 May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Isopto Carpine (pilocarpine hydrochloride237 06/22/2010 Meeting 05/07/2012 May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Kapvay (clonidine hydrochloride)238 09/28/2010 Meeting 09/11/2012 September 11, 2012 - Committee recommended harmonizing labeling with the clonidine IR label for AV block and hallucinations, and return to standard, ongoing monitoring for adverse events. February, 2013 - Revised Label239
Vyvanse (lisdexamfetamine dimesylate)240 11/10/2010 Meeting 09/11/2012 September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events and to be notified after class labeling for ADHD medications is completed.
Beyaz (drospirenone/ethinyl estradiol/ levomefolate calcium tablets and levomefolate calcium tablets)241 09/24/2010 Meeting 09/11/2012 September 11, 2012 - The Committee raised concerns about the risk of venous thromboembolism with drospirenone products, and asked that FDA consider strengthening the label. They expressed the need for studies/assessments in the younger adolescent population. Though the majority voted for a return to routine monitoring there were many “conditions” applied please see Minutes of the Meeting.242
ella (ulipristal acetate)243 08/13/2010 Meeting 09/11/2012 September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate)244 10/21/2010 Meeting 09/11/2012 September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Afinitor (everolimus)245 10/29/2010 Meeting 09/11/2012 September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Ofirmev (acetaminophen)246 11/02/2010 Meeting 09/11/2012 September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events, and recommended labeling for every 4 hours versus every 6 hours, and discussed having only mg dosing in the label.
Lastacaft (alcaftadine)247 07/28/2010 Meeting 09/11/2012 September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Aridol (mannitol inhalation powder) Bronchial Challenge Test Kit248 10/05/2010 Meeting 09/11/2012 September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Augmentin XR (amoxicillin/clavulanate potassium)249 08/27/2010 Meeting 09/11/2012 September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Melody Transcatheter Pulmonary Valve and Ensemble Delivery System250
mandated annual review
01/25/2010 Meeting 09/11/2012 September 11, 2012 - Committee agreed that the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
Elana Surgical Kit (HUD)251, initial review 03/10/2011 Meeting 09/11/2012 September 11, 2012 - Committee agreed that the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
MENACTRA Meningococcal Polysaccharide (Serogroup A, C, Y and W/20135) Diphtheria Toxoid Conjugate Vaccine252 04/22/2011 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to routine monitoring for adverse events and follow-up information on the Post-market Commitment Stage 1 study in 9-23 month olds after the data is reviewed.
HIZENTRA Immune Globulin Subcutaneous (Human) 20% Liquid253 02/17/2011 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events. More utilization information is needed for the CBER products.
ALIMTA (pemetrexed disodium)254 03/17/2011 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to ongoing monitoring for adverse events.
GADAVIST (gadobutrol)255 03/14/2011 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to ongoing monitoring for adverse events. Committee discussed the issues of the cases being confounded and hypersensitivity reactions may be related to latex or other drugs.
KEDBUMIN Albumin (Human)256 06/01/2011 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee recommended that more utilization data be available for review of the CBER products.
NATROBA (spinosad)257 01/18/2011 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events.
UROXATRAL (alfuzosin hydrochloride)258 12/15/2010 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events.
CREON (pancrelipase)259 06/10/2011 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events.
ZENPEP (pancrelipase)260 06/15/2011 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events.
MOXEZA (moxifloxacin ophthalmic solution 0.5%)261 11/19/2010 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events. Recommended post-marketing commitment studies on repeat exposures to ophthalmic agents to check for allergic reactions.
KYTRIL INJECTION (granisetron hydrochloride)262 04/29/2011 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee requested follow-up on labeling for serotonin syndrome in the warnings and concomitant medication class of 5HT3
NEXIUM (esomeprazole magnesim) & NEXIUM IV (esomeprazole sodium)263 12/15/2011 & 04/29/2011 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee requested labeling changes in the indications section.
INOMAX (nitric oxide)264 12/21/2010 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee requested further information on risk factors for bronchopulmonary disease. Committee was divided on whether to report to both FAERS and MAUDE for postmarketing reporting or to either system.
ACTEMRA (tocilizumab)265 04/15/2011 Meeting 03/14/2013 March 14, 2013 - Committee recommended routine monitoring with return to the PAC in 2 years with CARRA data. Discussion about pulmonary hypertension and continued surveillance and additional data from registries to monitor for SAEs.
LAMICTAL XR (lamotrigine)266 04/25/2011 Meeting 03/14/2013 March 14, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events. Recommended changing the labels’ warning section related to breathing problems in infants who are breastfeeding from mothers who are on Lamictal XR.
INVEGA (paliperidone)267 04/06/2011 Meeting 03/14/2013 March 14, 2013 - Committee recommended routine follow-up with return to them when the Pediatric Long-Term Safety Study data on weight gain, lipid effects, glucose effects and insulin is analyzed.
Cervarix, Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant268 07/19/2011 Meeting 09/19/2013 September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events. They requested an update report when current, ongoing postmarketing safety studies become available.
Chantix (varenicline tartrate)269 11/09/2011 Meeting 09/19/2013 September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events. They thought more information on safety and use data in children <12 years of age was needed. PAC requested an update when study results are submitted to FDA in 2016.
Copegus & Pegasys (ribavirin & peginterferon alfa-2a)270 08/22/2011 Meeting 09/19/2013 September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.
Faslodex (fulvestrant)271 05/17/2011 Meeting 09/19/2013 September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.
Gammagard Liquid, [Immune Globulin Infusion (Human)] 10%272 07/22/2011 Meeting 09/19/2013 September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.
HEMACORD (hematopoietic progenitor cell, cord blood)273 11/10/2011 Meeting 09/19/2013 September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.
Intuniv (guanfacine)274 07/28/2010 Meeting 09/19/2013 September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.
Isentress (raltegravir)275 12/21/2011 Meeting 09/19/2013 September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.
Ixempra Kit (ixabepilone)276 10/18/2011 Meeting 09/19/2013 September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.
Plavix (clopidogrel bisulfate)277 05/06/2011 Meeting 09/19/2013 September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.
Topamax (topiramate)278 07/15/2011 Meeting 09/19/2013 September 19-20, 2013 - Committee requested further analysis of both serious and non-serious cognitive and developmental, neurologic, and metabolic adverse events, such as Alice-in-Wonderland syndrome, and liver function test elevation in the 2-10 year olds treated for migraines.
Berlin Heart Inc. EXCOR Pediatric Ventricular Assist Device279, initial review 12/16/2011 Meeting 09/19/2013 September 19-20, 2013 - Committee agreed that the HDE device is appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
Elana Surgical Kit (HUD)280mandated annual review 03/10/2011 Meeting 09/19/2013 September 19-20, 2013 - Committee agreed that the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
Melody Transcatheter Pulmonary Valve Therapy281mandated annual review 01/25/2010 Meeting 09/19/2013 September 19-20, 2013 - Committee agreed that the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
Advate[Antihemophilic Factor (Recombinant)]282
Advate
12/14/2011 Meeting 04/21/2014 April 21, 2014 - Pediatric Advisory Committee (PAC) recommended return to standard, ongoing monitoring for adverse events.
Famvir (famciclovir)283 02/09/2012 Meeting 04/21/2014 April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.
Intelence (etravirine)284 03/26/2012 Meeting 04/21/2014 April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.
Keppra (levetiracetam)285 12/16/2011 Meeting 04/21/2014 April 21, 2014 - PAC suggested assessing off-label use in the younger age group and use for mood disorders. PAC recommended return to standard, ongoing monitoring for adverse events.
Maxalt and Maxalt-MLT (rizatriptan)286 12/16/2011 Meeting 04/21/2014 April 21, 2014 - PAC inquired and was informed that there was not a contraindication to giving Maxalt and Topamax together. PAC recommended return to standard, ongoing monitoring for adverse events.
Natazia (estradiol valerate and estradiol valerate/diengest)287 03/14/2012 Meeting 04/21/2014 April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.
Pertzye (pancrelipase)288 05/17/2012 Meeting 04/21/2014 April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.
Prezista (darunavir)289 12/16/2011 Meeting 04/21/2014 April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.
Reyataz (atazanavir)290 10/17/2011 Meeting 04/21/2014 April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.
Sklice (ivermectin)292 02/17/2012 Meeting 04/21/2014 April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.
TISSEEL (Fibrin Sealant)293 01/25/2012 Meeting 04/21/2014 April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.
Torisel (temsirolimus)294 05/30/2012 Meeting 04/21/2014 April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.
Ultresa (pancrelipase)295 03/01/2012 Meeting 04/21/2014 April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.
Viread (tenofovir disoproxil fumarate)296 01/18/2012 Meeting 04/21/2014 April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.
Medtronic Activa Dystonia Therapy297, initial review 01/16/2013 Meeting 04/21/2014 April 21, 2014 - The PAC discussed several issues including:
·shorter battery lifespan in patients with dystonia, migration and lead breakage CVA as a pre-existing condition, and as a complication of surgery or reimplantation; safety surveillance to better understand the impact on cognitive and motor abilities, particularly in the younger children if there was any relationship between adverse events and whether the procedures were performed in children’s hospitals, or other facilities. Committee agreed that the HDE device is appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
Vertical Expandable Prosthetic Titanium Rib (VEPTR)298 11/29/2012 Meeting 04/21/2014 April 21, 2014 - The PAC discussed the complications of the procedure and concerns about capturing adverse events specifically for the < 6 month olds Committee agreed that the HDE device is appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
Afinitor Disperz (everolimus)299 08/29/2012 Meeting 09/23/2014 September 23, 2014 - Committee recommended return to standard, ongoing monitoring for adverse events.
Levaquin (levofloxacin)300 04/27/2012 Meeting 09/23/2014 September 23, 2014 - Committee was concerned about long-term use in children <12 years of age, and various ways to collect and monitor use data. Committee recommended return to standard, ongoing monitoring for adverse events.
Lexiva (fosamprenavir)301 04/27/2012 Meeting 09/23/2014 September 23, 2014 - Committee recommended return to standard, ongoing monitoring for adverse events.
Treanda (bendamustine hydrochloride)302 06/26/2012 Meeting 09/23/2014 September 23, 2014 - Committee recommended return to standard, ongoing monitoring for adverse events.
Viread (tenofovir disoproxil fumarate)303 08/16/2012 Meeting 09/23/2014 September 23, 2014 - Committee recommended return to standard, ongoing monitoring for adverse events.
Menhibrix (meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine)304 06/14/2012 Meeting 09/23/2014 September 23, 2014 - Committee recommended return to standard, ongoing monitoring for adverse events.
Singulair (montelukast sodium)305 03/26/2012 Meeting 09/23/2014 September 23, 2014 - The Committee discussed improving the professional product label with respect to the description of neuropsychiatric events. They made a recommendation for those patients experiencing a NP event, that they should stop the therapy and contact their provider about the risks and benefits of continuing the therapy, instead of continuing it while waiting to discuss the risk-benefit. The Committee recommended a review and update of the labeling for plain language in the consumer information section related to important side effects, and to also send a related information letter to providers. PAC recommended return to standard, ongoing monitoring for adverse events.
Voluven (6% Hydroxyethyl Starch 130/0.4 in 0.9% sodium chloride injection306 05/12/2012 Meeting 09/23/2014 September 23, 2014 - Committee recommended return to standard, ongoing monitoring for adverse events.
Berlin Heart EXCOR Pediatric Ventricular Assist Device307, mandated annual review 12/16/2011 Meeting 09/23/2014 September 23, 2014 - Committee agreed that the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
CONTEGRA Pulmonary Valved Conduit308, initial review 04/15/2013 Meeting 09/23/2014 September 23, 2014 - Committee agreed that the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
Elana Surgical Kit HUD309, mandated annual review 03/10/2011 Meeting 09/23/2014 September 23, 2014 - Committee agreed that the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
Enterra Gastric Electrical Stimulator310initial review 03/25/2013 Meeting 09/23/2014 September 23, 2014 - Committee agreed that FDA routine monitoring was not enough and they recommended (1) Medtronic do systematic collection of data in less than 21 years old for adverse events, and (2) patient labeling to be evaluated and appropriate information from the physician labeling be added to the patient labeling. Committee discussed concerns about difficulties with diagnosis, risk mitigation, off-label use in <18 year olds, and inconsistencies in the patient and physician labeling.
Medtronic Melody Transcatheter Pulmonary Valve311, mandated annual review 01/25/2010 Meeting 09/23/2014 September 23, 2014 - Committee agreed that the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
Dymista (azelastine hydrochloride and fluticasone proprionate)312 05/01/2012 Meeting 03/24/2015 March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.
QNASL (beclomethasone dipropionate)313 03/23/2012 Meeting 03/24/2015 March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.
Venofer (iron sucrose)314 09/21/2012 Meeting 03/24/2015 March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.
Invirase (saquinavir)315 11/30/2012 Meeting 03/24/2015 March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.
Cymbalta (duloxetine hydrochloride)316 10/18/2012 Meeting 03/24/2015 March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.
Quillivant XR (methphenidate hydrochloride)317 09/27/2012 Meeting 03/24/2015 March 24, 2015 - Committee recommended that anger and irritability should be moved to a more prominent place in the labeling, that preparation of the drug by the pharmacist needs to be highlighted at the beginning of instructions, and FDA should explore ways in which parents and caregivers could be better informed that mg and ml are not equivalent doses. PAC recommended return to standard, ongoing monitoring for adverse events.
Risperdal (risperidone)318 08/02/2012 Meeting 03/24/2015 March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.
Lunesta (eszopiclone)319 10/10/2012 Meeting 03/24/2015 March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.
Oxtellar XR (oxcarbazepine extended-release)320 10/19/2012 Meeting 03/24/2015 March 24, 2015 - Committee agreed with FDA’s proposed label changes for hypothyroidism to be added to the Postmarketing section of the label, and recommended return to standard, ongoing monitoring for adverse events.
Revatio (sildenafil)321 03/06/2014 & 08/30/2012 Meeting 03/24/2015 March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.
Advair HFA (fluticasone propionate/salmeterol xinafoate)322 12/19/2012 Meeting 03/24/2015 March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events
Altabax Ointment (retapamulin)323 12/21/2012 Meeting 03/24/2015 March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events
FluMist Quadrivalent (Influenza Vaccine Live, Intranasal)324 02/29/2012 Meeting 03/24/2015 March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.
Fluarix Quadrivalent (Influenza Virus Vaccine)325 02/14/2012 Meeting 03/24/2015 March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.lotensilosuprane
Liposorber LA-15 System326, mandated annual review 10/10/2013 Meeting 03/24/2015 March 24, 2015 - Committee recommended to extend the postmarket study to obtain long-term outcomes. Committee agreed that the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
Medtronic Activa Dystonia Therapy327, mandated annual review 01/16/2013 Meeting 03/24/2015 March 24, 2015 - Committee agreed that the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing
Zylet (loteprednol etabonate and tobramycin) 02/10/2013 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Viramune XR (nevirapine) 10/08/2012 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Recothrom [thrombin, topical (recombinant)] 03/15/2013 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Prezista (darunavir) 02/01/2013 & 04/24/2013 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Prevnar 13 [Pneumoccal 13 – conjugate vaccine (Diphtheria CRM197)] 01/25/2013 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring and agreed with the FDA plan for follow-up after investigation with the FDA Post-licensure Rapid Immunization Safety Monitoring System (PRISM) for Kawasaki disease (KD).
Phenylephrine Hydrochloride 03/21/2013 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Intelence (etravirine) 02/27/2013 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Fycompa (perampanel) 10/22/2012 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Exjade (deferasirox) 01/23/2013 Meeting 09/16/2015 September 16, 2015 - Committee members agreed to the FDA plan to continue ongoing safety monitoring and discussed the SAEs found in FAERS with off-label use in <2 year olds.They asked that FDA look for data on children with fever taking Exjade, and report back to the PAC if there is determined to be a safety concern in this population. Review Update, 9/14/16
Epiduo (adapalene and benzoyl peroxide) 02/01/2013 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Durezol (difluprednate) 03/22/2013 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Dotarem (gadoterate meglumine) 03/20/2013 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Bethkis (tobramycin) 10/12/2012 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Pleximmune, initial review 08/26/2014 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.The committee discussed that there would probably be few if any adverse event reports submitted to FDA related to the false-negative or false-positive results of the test, given that it is an adjunct to clinical decision making based on biopsy and other laboratory testing.
Berlin Heart EXCOR Pediatric Ventricular Assist Device, mandated annual review 12/16/2011 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
CONTEGRA Pulmonary Valved Conduit, mandated annual review 04/15/2013 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Elana Surgical Kit HUD, mandated annual review 03/10/2011 Meeting 09/16/2015 September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Enterra Gastric Electrical stimulator, mandated annual review 03/25/2013 Meeting 09/16/2015 September 16, 2015 – Committee members brought up the concern of off-label use in children less than 18 years of age with this device. Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Aciphex Sprinkles (rabeprazole sodium) 03/26/2013 Meeting 04/12/2016 April 12, 2016 - Committee members agreed with the FDA recommendations to add vertigo and blurred vision to prescribing information for all dosage forms of Aciphex.
Skyla (levonorgestrel releasing intrauterine system) 01/09/2013 Meeting 04/12/2016 April 12, 2016 - Committee members agreed with the FDA plan to continue ongoing safety monitoring.
Mycamine (micafungin sodium) 06/21/2013 Meeting 04/12/2016 April 12, 2016 - Committee members agreed with the FDA plan to continue ongoing safety monitoring.
Noxafil (posaconazole) 11/25/2013 Meeting 04/12/2016 April 12, 2016 - (1) Committee members agreed with the FDA plan to continue ongoing safety monitoring. (2) Committee agreed with FDA's review plan to report back to the PAC regarding drug interactions between Noxafil andvincristine and/or midazolam, as well as other drugs which are metabolized by the CYP3A pathway (other benzodiazepines), and consider and appropriate labeling change.
Precedex (dexmedetomidine hydrochloride) 06/17/2013 Meeting 04/12/2016 April 12, 2016 - (1) Committee members agreed that an Advisory Committee is needed to review further data on dexmedetomidine, and also on the broader concerns about use of general anesthetics and sedatives in infants and young children. (2) Committee members agreed with the FDA plan to continue ongoing safety monitoring.
Xeloda (capecitabine) 12/10/2013 Meeting 04/12/2016 April 12, 2016 - Committee members agreed with the FDA plan to continue ongoing safety monitoring.
Vyvanse Capsule (lisdexamfetamine dimesylate) 04/26/2013 Meeting 04/12/2016 April 12, 2016 - Committee members agreed with the FDA plans to (1) continue ongoing safety monitoring, and (2) review the safety signal for alopecia and bring the information to the committee at a future date. (3) Committee members agreed that FDA should explore the use of claims database to obtain information regarding suicidality.
Seroquel (quetiapine fumarate) & Seroguel XR (quetiapine fumarate extended release) 04/30/2013 Meeting 04/12/2016 April 12, 2016 - Committee members agreed with the FDA plan to continue ongoing safety monitoring.
Symbyax (fluoxetine hydrochloride and olanzapine) 07/26/2013 Meeting 04/12/2016 April 12, 2016 - Committee members agreed with the FDA plan to continue ongoing safety monitoring.
Sabril (vigabatrin) 10/26/2013 Meeting 04/12/2016 April 12, 2016 - Committee members agreed with FDA's plan to continue ongoing safety monitoring.
FluLaval Quadrivalent (Influenza Vaccine) 07/26/2013 Meeting 04/12/2016 April 12, 2016 - Committee members agreed with the FDA plan to continue ongoing safety monitoring.
FluLaval (Influenza Vaccine) 08/16/2013 Meeting 04/12/2016 April 12, 2016 - Committee members agreed with the FDA plan to continue ongoing safety monitoring.
Fluzone Quadrivalent (Influenza Vaccine) 06/07/2013 Meeting 04/12/2016 April 12, 2016 - Committee members agreed with the FDA plan to continue ongoing safety monitoring.
Medtronic Activa Dystonia Therapy, mandated annual review 01/16/2013 Meeting 04/12/2016 April 12, 2016 - Committee members agreed the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
Liposorber LA-15 System, mandated annual review 10/10/2013 Meeting 04/12/2016 April 12, 2016 - Committee members agreed the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
Impella RP System, initial review 01/23/2015 Meeting 04/12/2016 April 12, 2016 - Committee members agreed the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.

 

 

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