Science & Research

Safety Reporting

Listed below are the products that have had a report on adverse events presented to the Pediatric Advisory Committee. 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)).

(Search results update automatically as you type)
 

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DrugDate Exclusivity GrantedPediatric Labeling Change DatePAC DatePediatric Advisory Committee Recommendations and Subsequent Outcomes

Zoloft (sertraline)16

02/01/2002-06/12/2003

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).

Ditropan (oxbutynin)02/28/2002 11/16/2006November 16, 2006 (review update for QT Prolongation with Celexa and Lexapro) - Recommend routine monitoring for AEs in all populations

Ditropan (oxybutynin)17

02/08/2002-06/12/2003

June 12, 2003 - PS requested future review after additional marketing experience.
November 16, 2006 - Preliminary reassessment.
February 6, 2008 - revised label

Ditropan (oxybutynin)17

02/08/2002-04/11/2007

April 11, 2007 (Follow-up) - The PAC requested labeling to include additional information concerning postmarketing 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

02/22/2002-06/12/2003

June 12, 2003 - PS requested future review after additional marketing experience.

Lipitor (atorvastatin)18

02/22/2002-11/16/2006

November 16, 2006 (Follow-up) - Committee recommended return to routine monitoring for adverse events (AEs) in all populations.

Zocor (simvastatin)19

02/22/2002-06/12/2003

June 12, 2003 - PS requested future review after additional marketing experience.

Zocor (simvastatin)19

02/22/2002-11/16/2006

November 16, 2006 (Follow-up) - Pediatric Advisory Committee recommended return to routine monitoring for AEs in all populations.

Busulfex (busulfan)20

03/12/2002-10/29/2003

October 29, 2003 - PS recommended return to routine monitoring for AEs in all populations.

Zyrtec (cetirizine)21

03/13/2002-10/29/2003

October 29, 2003 - Committee recommended return to routine monitoring for AEs in all populations.

Cozaar (losartan)22

03/20/2002-10/29/2003

October 29, 2003 - Committee recommended return to routine monitoring for AEs in all populations.

Nolvadex (tamoxifen)23

05/16/2002-10/29/2003

October 29, 2003 - Committee recommended return to routine monitoring for AEs in all populations.

Accupril (quinapril)24

06/07/2002-10/29/2003

October 29, 2003 - Committee recommended return to routine monitoring for AEs in all populations.

Serzone (nefazodone)25

06/27/2002-10/29/2003

October 29, 2003 - For additional information regarding PS recommendations and outcomes for SSRIs see Zoloft (sertraline HCl).

Paxil (paroxetine)26

06/27/2002-02/03/2004

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

07/10/2002-02/03/2004

February 3, 2004 - PS recommended return to routine monitoring for AEs in all populations.

Celexa (citalopram)28

07/12/2002-02/03/2004

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

07/12/2002-11/16/2006

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

08/15/2002-02/03/2004

February 3, 2004 - PS recommended return to routine monitoring for AEs in all populations.

Hycamtin (topotecan)30

11/20/2002-06/09/2004

June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.

Temodar (temozolomide)31

11/20/2002-06/09/2004

June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.

Effexor (venlafaxine)32

12/02/2002-06/09/2004

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

01/10/2003-06/09/2004

June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.

Ciloxan (ciprofloxacin)34

01/10/2003-06/09/2004

June 9, 2004 - Committee recommended return to routine monitoring for AEs in all populations.

Monopril (fosinopril)35

01/27/2003-06/09/2004

June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.

Allegra (fexofenadine)36

01/27/2003-06/09/2004

June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.

Duragesic (fentanyl)37

01/29/2003-06/09/2004

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

11/12/2002-09/15/2004

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

02/12/2003-09/15/2004

September 15, 2004 - Committee recommended return to routine monitoring for AEs in all populations.

Cutivate/Flonase/Flovent (fluticasone),42
Advair (fluticasone and salmeterol)43

02/25/2003-09/15/2004

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

03/12/2003-09/15/2004

September 15, 2004 - Committee recommended return to routine monitoring for AEs in all populations.

Fludara (fludarabine)45

04/03/2003-09/15/2004

September 15, 2004 - Committee recommended return to routine monitoring for AEs in all populations.

Fosamax (alendronate)46

04/28/2003-09/15/2004

September 15, 2004 - Committee recommended return to routine monitoring for AEs in all populations.

Lotensin (benazepril)47

07/02/2003-02/14/2005

February 14, 2005 - Committee recommended continued close monitoring of benazepril in the pediatric population for future review.

Lotensin (benazepril)47

07/02/2003-03/25/2008

March 25, 2008 (Follow-up) - Committee recommended return to routine monitoring for AEs in all population

Malarone (atovaquone/proguanil)48

08/06/2003-02/14/2005

February 14, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Brevibloc (esmolol)49

08/22/2003-02/14/2005

February 14, 2005 - Committee recommended to continue monitoring and provide future review.

Brevibloc (esmolol)49

08/22/2003-03/25/2008

March 25, 2008 (Follow-up) - Committee recommended return to routine monitoring for AEs in all populations.

Viracept (nelfinavir)50

09/04/2003-02/14/2005

February 14, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Xenical (orlistat)51

09/12/2003-02/14/2005

February 14, 2005 - Committee recommended continued monitoring and future review for the risk of cholelithiasis;

Xenical (orlistat)51

09/12/2003-04/11/2007

April 11, 2007 (Follow-up) - Committee recommended return to routine monitoring for AEs in all populations.

Glucovance (glyburide/metformin)52

10/08/2003-02/14/2005

February 14, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Arava (leflunomide)53

11/10/2003-06/30/2005

June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Concerta (methylphenidate)54

12/04/2003-06/30/2005

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

12/08/2003-06/30/2005

June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Zomig (zolmitriptan)57

12/18/2003-06/30/2005

June 30, 2005 -Committee recommended return to routine monitoring for AEs in all populations.

Ortho-Tri-Cyclen (ethinyl estradiol; norgestimate)58

12/18/2003-06/30/2005

June 30, 2005 -Committee recommended return to routine monitoring for AEs in all populations.

Cipro (ciprofloxacin)59

12/18/2003-06/30/2005

June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Trusopt (dorzolamide)60

01/05/2004-06/30/2005

June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Detrol;Detrol LA (tolterodine)61

01/05/2004-06/30/2005

June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Agrylin (anagrelide)62

05/24/2004-11/18/2005

November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Paraplatin (carboplatin)63

04/30/2004-11/18/2005

November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Diflucan (fluconazole)64

01/21/2004-11/18/2005

November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Camptosar (irinotecan)65

03/10/2004-11/18/2005

November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Tamiflu (oseltamivir phosphate)66

03/22/2004-11/18/2005

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

03/22/2004-11/16/2006

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

03/22/2004-11/27/2007

November 27, 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

02/18/2004-11/18/2005

November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Ferrlecit (sodium ferric gluconate complex in sucrose injection)69

03/24/2004-11/18/2005

November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Imitrex (sumatriptan)70

02/18/2004-11/18/2005

November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.

Avapro (irbesartan)71

09/16/2004-03/22/2006

March 22, 2006 - Committee recommended return to routine monitoring for AEs in all populations.

Clolar (clofarabine)72

03/30/2004-03/22/2006

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

10/28/2004-03/22/2006

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

10/06/2004-03/22/2006

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

11/17/2004-11/16/2006

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

12/01/2004-11/16/2006

November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.

Avandia (rosiglitazone)79

12/09/2004-11/16/2006

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

01/27/2005-11/16/2006

November 16, 2006 Committee recommended return to routine monitoring for AEs in all population- s.

Invanz (ertapenem)81

02/11/2005-11/16/2006

November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.

Zyvox (linezolid)82

02/11/2005-11/16/2006

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

02/11/2005-11/18/2008November 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

03/02/2005-11/16/2006

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

03/02/2005-03/08/2008

March 8, 2008 (Follow-up) - Preliminary review of pediatric subpopulation. Further evaluation of entire of adult and pediatric populations pending.

Mobic (meloxicam)84

04/15/2005-11/16/2006

November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.

Novolog (insulin aspart recombinant)85

05/24/2005-11/16/2006

November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.

Amaryl (glimepiride)86

06/09/2005-11/16/2006

November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.

Norvir (ritonavir)87

06/14/2005-11/16/2006

November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.

Lescol (fluvastatin)88

12/15/2005-04/11/2007

April 11, 2007 - Committee recommended routine monitoring for AEs in all populations.

Sandostatin (octreotide)89

01/12/2006-04/11/2007

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

01/12/2006-11/18/2008

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

03/09/2006-11/28/2007

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 10/2011, 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

03/21/2006-11/28/2007

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

Emtrivia (emtricitabine)93

05/24/2006-11/28/2007

November 28, 2007 - Committee recommended return to routine monitoring for AEs in all populations.

Gleevec (imatinib mesylate)94

06/09/2006-11/28/2007

November 28, 2007 - Committee recommended return to routine monitoring for AEs in all populations.

Azopt (Brinzolamide)95

06/28/2006-11/28/2007

November 28, 2007 - Committee recommended return to routine monitoring for AEs in all populations.

Betaxon (levobetaxolol)96

06/28/2006-11/28/2007

November 28, 2007 - No recommendations. This drug is not marketed.

Toprol XL (metoprolol)97

07/27/2006-03/25/2008

March 25, 2008- Committee recommended return to routine monitoring for AEs in all populations.

Celebrex (celecoxib)98

08/23/2006-03/25/2008

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

08/23/2006-03/25/2008

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

09/13/2006-03/25/2008

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

09/13/2006-06/21/2010

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

09/27/2006-03/25/2008

March 25, 2008 - Committee recommended return to routine monitoring for AEs in all populations.

Coreg (carvedilol)103

11/08/2006-03/25/2008

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

11/20/2006-11/18/2008

November 18, 2008 - Committee recommended that FDA continue its standard, ongoing safety monitoring.

Lamisil (terbinafine)105

12/04/2006-11/18/2008

November 18, 2008 - Committee recommended that FDA continue its standard, ongoing safety monitoring.

Aldara (imiquimod)106

12/13/2006-11/18/2008

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

01/10/2007-11/18/2008

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

02/14/2007-11/18/2008

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

02/28/2007-11/18/2008

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

02/28/2007-11/18/2008

November 18, 2008 - Committee recommended that FDA return to routine monitoring for AEs

Timolol GFS (timolol)115

02/28/2007-11/18/2008

November 18, 2008 - Committee recommended that FDA return to routine monitoring for AEs

Levaquin (levofloxacin)116

03/14/2007-11/18/2008

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.
April 27, 2009 - revised label.

Combigan (brimonidine/timolol)117

-10/30/200706/23/2009

June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.

Derma-Smoothe/FS (fluocinolone acetonide)118

-12/12/200706/23/2009

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

-12/19/200706/23/2009

June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.

Inspra (eplerenone)120

-01/31/200806/23/2009

June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.

Moxatag (amoxicillin)121

-01/23/200806/23/2009

June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.

Alvesco (ciclesonide)122

-01/10/200806/23/2009

June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.

Omnaris (ciclesonide)123

-11/21/200706/23/2009

June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs

Zometa (zoledronic acid)124

-03/20/200806/23/2009

June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.

Diovan (valsartan)125

-11/29/200706/23/2009

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

-02/01/200806/23/2009

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

-12/27/200706/23/2009

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

-03/24/200806/23/2009

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

-06/05/200812/08/2009

December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.

Aptivus (tipranavir)131

-06/23/200812/08/2009

December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.

Reyataz (atazanavir Sulfate)132

-03/25/200812/08/2009

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
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

-05/05/200812/08/2009

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

-12/27/200712/08/2009

December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.

Evicel [fibrin sealant (human)]137

-01/02/200812/08/2009

December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.

Artiss [fibrin sealant (human)]138

-03/19/200812/08/2009

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

-07/29/200812/08/2009

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

-03/26/200812/08/2009

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

-04/07/200812/08/2009

December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.

Humira (adalimumab)143

-02/21/200812/08/2009

December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.

Abilify (aripiprazole)144

-10/29/2007
02/27/2008
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

-03/31/200803/22/2010

March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Cardiolite (technetium Tc99m)146

-04/30/200803/22/2010

March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Nasacort AQ (triamcinolone)147

-09/19/200803/22/2010

March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Viramune (nevirapine)148

-06/24/200803/22/2010

March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Daptacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)149

-03/12/200803/22/2010

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

-06/24/200803/22/2010

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

-06/20/200803/22/2010

March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Rotarix (Rotavirus Vaccine, Live, Oral)152

-04/03/200803/22/2010

March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Valtrex (valacyclovir)153

-09/03/200803/22/2010

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

-10/08/200803/22/2010

March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Casodex (bicalutamide)155

-12/19/200806/21/2010

June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Apidra (insulin glulisine recombinant)156

-10/24/200806/21/2010

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

-03/14/200806/21/2010

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

-12/05/200806/21/2010

June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Desmopressin Acetate159

-05/08/200806/21/2010

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

-10/28/200806/21/2010

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
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

-06/30/200806/21/2010

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

-03/20/200806/21/2010

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

-05/09/200806/21/2010

June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Zemuron (rocuronium)165

-08/28/200806/21/2010

June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Kogenate FS (antihemophilic factor (recombinant))166

-10/10/200806/21/2010

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

-10/21/200812/07/2010

December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Ulesfia Lotion 5% (benzl alcohol)168

-04/09/200912/07/2010

December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Epiduo Gel (adapalene & benzoyl peroxide)169

-12/17/200812/07/2010

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

-09/12/200812/07/2010

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

-08/21/200912/07/2010

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

-07/01/200812/07/2010

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

-11/14/200812/07/2010

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

-12/18/200812/07/2010

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

-12/11/200812/07/2010

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

-04/30/200912/07/2010

December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.

Lamictal XR (lamotrigine)177

-05/29/2009
01/29/2010
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)

-05/08/200912/07/2010

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

-08/19/200905/16/2011

May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Bepreve (bepotastine besilate)179

-09/08/200905/16/2011

May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Besivance (besifloxacin)180

-05/28/200905/16/2011

May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Cetraxal (ciprofloxacin otic)181

-05/01/0905/16/2011

May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Patanase Spray (olopatadine hydrochloride)182

-04/15/2008
12/01/2009
05/16/2011

May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Astepro spray(azelastine hydrocholoride)183

-08/31/200905/16/2011

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

-10/15/200905/16/2011

May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Welchol (colesevelam)185

-10/02/200905/16/2011

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

-09/02/200905/16/2011

May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Lexapro (escitalopram oxalate)187

-03/19/200905/16/2011

May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Actonel (risedronate)188

-07/23/200905/16/2011

May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Valcyte (valganciclovir)189

-08/28/200905/16/2011

May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Retrovir (zidovudine)190

-09/19/2008
11/06/2009
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

-12/19/200809/22/2011

September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Topamax (topiramate)193

-12/22/200909/22/2011

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

-07/24/200809/22/2011

September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Akten Ophthalmic (lidocaine hydrochloride ophthalmic gel 3.5%)196

-10/07/200809/22/2011

September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Triesence (trimcinolone acetonide injectable suspension)197

-11/29/200709/22/2011

September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Melody Transcatheter Pulmonary Valve and Ensemble Delivery System198

-01/25/201009/22/2011

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

-10/19/200909/22/2011

September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

AFLURIA Infuenza virus vaccine200

-11/10/200909/22/2011

September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Famvir (famciclovir)201

-12/24/200909/22/2011

September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Videx EC (didanosine)202

-09/29/200809/22/2011

September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Abilify (aripiprazole)203

-11/19/200909/22/2011

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

-10/14/200809/22/2011

September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.

Levaquin (levofloxacin)206

-05/05/200809/22/2011

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

-12/23/200901/30/2012

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
01/30/2012

January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Seroquel (quetiapine fumarate)209

-12/02/200901/30/2012

January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Xolair (omalizumab)210

-01/04/201001/30/2012

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

-07/10/200901/30/2012

January 30, 2012 Committee recommended return to standard, ongoing monitoring for adverse events.

Flomax (tamsulosin hydrochloride)212

-12/22/200901/30/2012

January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Atacand (candesartan cilexetil)213

-10/22/200901/30/2012

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

-02/04/201001/30/2012

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

-04/12/201001/30/2012

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

-08/27/200901/30/2012

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

-04/30/200901/30/2012

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

-07/31/200901/30/2012

January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Mirena (levonorgestrel releasing intrauterine system)220

-10/01/200901/30/2012

January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Prevnar 13 [pneumococcal 13-valent conjugate vaccine (diptheria CRM197 protein)]221

-02/24/201001/30/2012

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
01/30/2012

January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Tamiflu (oseltamivir phosphate)223

-02/22/201005/07/2012

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

-03/24/201005/07/2012

May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Differin (adapalene)225

-03/17/201005/07/2012

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

-03/17/201005/07/2012

May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Dulera (formoterol fumarate; mometasone furoate)227

-06/22/201005/07/2012

May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events in the 5/2011 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
05/07/2012

May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Taxotere (docetaxel)229

-05/13/201005/07/2012

May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Omnaris (ciclesonide)230

-05/07/201005/07/2012

May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Natazia (dienogest; estradiol valerate)231

-05/06/201005/07/2012

May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Protonix (pantoprazole sodium)232

-11/12/200905/07/2012

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
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
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

-05/18/201005/07/2012

May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Zylet (loteprednol etabonate and tibramycin)236

-06/03/1005/07/2012

May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Isopto Carpine (pilocarpine hydrochloride237

-06/22/201005/07/2012

May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Kapvay (clonidine hydrochloride)238

-09/28/201009/11/2012

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

-11/10/201009/11/2012

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

-09/24/201009/11/2012

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

-08/13/201009/11/2012

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

-10/21/201009/11/2012

September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Afinitor (everolimus)245

-10/29/201009/11/2012

September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Ofirmev (acetaminophen)246

-11/02/201009/11/2012

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

-07/28/201009/11/2012

September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Aridol (mannitol inhalation powder) Bronchial Challenge Test Kit248

-10/05/201009/11/2012

September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Augmentin XR (amoxicillin/clavulanate potassium)249

-08/27/201009/11/2012

September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.

Melody Transcatheter Pulmonary Valve and Ensemble Delivery System250
mandated annual review

-01/25/201009/11/2012

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

-03/10/201109/11/2012

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

-04/22/201103/14/2013

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

-02/17/201103/14/2013

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

-03/17/201103/14/2013

March 14, 2013 - Committee recommended return to ongoing monitoring for adverse events.

GADAVIST (gadobutrol)255

-03/14/201103/14/2013

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

-06/01/201103/14/2013

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

-01/18/201103/14/2013

March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events.

UROXATRAL (alfuzosin hydrochloride)258

-12/15/201003/14/2013

March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events.

CREON (pancrelipase)259

-06/10/1103/14/2013

March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events.

ZENPEP (pancrelipase)260

-06/15/201103/14/2013

March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events.

MOXEZA (moxifloxacin ophthalmic solution 0.5%)261

-11/19/201003/14/2013

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

-04/29/201103/14/2013

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 & 04/29/201103/14/2013

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

-12/21/201003/14/2013

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

-04/15/201103/14/2013

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

-04/25/201103/14/2013

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

-04/06/201103/14/2013

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

-07/19/201109/19/2013

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

-11/09/201109/19/2013

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

-08/22/201109/19/2013

September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.

Faslodex (fulvestrant)271

-05/17/201109/19/2013

September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.

Gammagard Liquid, [Immune Globulin Infusion (Human)] 10%272

-07/22/201109/19/2013

September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.

HEMACORD (hematopoietic progenitor cell, cord blood)273

-11/10/201109/19/2013

September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.

Intuniv (guanfacine)274

-07/28/201009/19/2013

September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.

Isentress (raltegravir)275

-12/21/201109/19/2013

September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.

Ixempra Kit (ixabepilone)276

-10/18/201109/19/2013

September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.

Plavix (clopidogrel bisulfate)277

-05/06/201109/19/2013

September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.

Topamax (topiramate)278

-07/15/201109/19/2013

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 2/2010 year olds treated for migraines.

Berlin Heart Inc. EXCOR Pediatric Ventricular Assist Device279

-12/16/201109/19/2013

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

-03/10/201109/19/2013

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

-01/25/201009/19/2013

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
-12/14/201104/21/2014

April 21, 2014 - Pediatric Advisory Committee (PAC) recommended return to standard, ongoing monitoring for adverse events.

Famvir (famciclovir)283

-02/09/2012

 

04/21/2014

April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.

Intelence (etravirine)284

-03/26/2012

 

04/21/2014

April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.

Keppra (levetiracetam)285

-12/16/201104/21/2014

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

-12/16/201104/21/2014

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

 

04/21/2014

April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.

Pertzye (pancrelipase)288

-05/17/201204/21/2014

April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.

Prezista (darunavir)289

-12/16/201104/21/2014

April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.

Reyataz (atazanavir)290

-10/17/201104/21/2014

April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.

Skli291ce (ivermectin)292

-02/17/2012

 

04/21/2014

April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.

TISSEEL (Fibrin Sealant)293

-01/25/2012

 

04/21/2014

April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.

Torisel (temsirolimus)294

-05/30/2012

 

04/21/2014

April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.

Ultresa (pancrelipase)295

-03/01/2012

 

04/21/2014

April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.

Viread (tenofovir disoproxil fumarate)296

-01/18/2012

 

04/21/2014

April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.

Medtronic Activa Dystonia Therapy297

-01/16/2013

 

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

 

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

 

09/23/2014

September 23, 2014 - Committee recommended return to standard, ongoing monitoring for adverse events.

Levaquin (levofloxacin)300

-04/27/2012

 

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

 

09/23/2014

September 23, 2014 - Committee recommended return to standard, ongoing monitoring for adverse events.

Treanda (bendamustine hydrochloride)302

-06/26/2012

 

09/23/2014

September 23, 2014 - Committee recommended return to standard, ongoing monitoring for adverse events.

Viread (tenofovir disoproxil fumarate)303

-08/12/201609/23/2014

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

 

09/23/2014

September 23, 2014 - Committee recommended return to standard, ongoing monitoring for adverse events.

Singulair (montelukast sodium)305

-03/26/2012

 

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

 

09/23/2014

September 23, 2014 - Committee recommended return to standard, ongoing monitoring for adverse events.

Berlin Heart EXCOR Pediatric Ventricular Assist Device307

-12/16/201109/23/2014

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

-04/15/2013

 

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

-03/10/201109/23/2014

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 Stimulator310

-03/25/2013

 

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

-01/25/201009/23/2014

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

 

03/24/2015

March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.

QNASL (beclomethasone dipropionate)313

-03/23/201203/24/2015

March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.

Venofer (iron sucrose)314

-09/21/201203/24/2015

March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.

Invirase (saquinavir)315

-11/30/201203/24/2015

March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.

Cymbalta (duloxetine hydrochloride)316

-10/18/201203/24/2015

March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.

Quillivant XR (methphenidate hydrochloride)317

-09/27/201203/24/2015

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

-08/02/201203/24/2015

March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.

Lunesta (eszopiclone)319

-10/10/201203/24/2015

March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.

Oxtellar XR (oxcarbazepine extended-release)320

-10/19/201203/24/2015

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
03/24/2015

March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.

Advair HFA (fluticasone propionate/salmeterol xinafoate)322

-12/19/201203/24/2015

March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events

Altabax Ointment (retapamulin)323

-12/21/201203/24/2015

March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events

FluMist Quadrivalent (Influenza Vaccine Live, Intranasal)324

-02/29/201203/24/2015

March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.

Fluarix Quadrivalent (Influenza Virus Vaccine)325

-02/14/201203/24/2015

March 24, 2015 - Committee recommended return to standard, ongoing monitoring for adverse events.lotensilosuprane

Liposorber LA-15 System326

-10/10/201303/24/2015

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

-1/16/201303/24/2015

March 24, 2015 - Committee agreed that the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing

 

 

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