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Safety Reporting

 

/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm341096.htmListed 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. To search this page, select "Edit" on the Explorer Menu Bar, select "Find on this Page", enter the search term in the "Find" box and click "Next".

 

N=246

DrugDate Exclusivity
Granted*
Date Reported to
Advisory Committee
**Pediatric Advisory Committee Recommendations and
Subsequent Outcomes
* PAC Reviews triggered by the Date Exclusivity Granted
Zoloft (sertraline)2-1-026-12-03February 2, 2004 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 (oxybutynin)2-8-026-12-03June 12, 2003 PS requested future review after additional marketing experience.
November 16, 2006 Preliminary reassessment.
April 11, 2007 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.  
February 6, 2008, revised label
Lipitor (atorvastatin)2-22-026-12-03June 12, 2003 PS requested future review after additional marketing experience.
November 16, 2006 Committee recommended return to routine monitoring for adverse events (AEs) in all populations.
Zocor (simvastatin)2-22-026-12-03June 12, 2003 PS requested future review after additional marketing experience.
November 16, 2006 Pediatric Advisory Committee recommended return to routine monitoring for AEs in all populations.
Busulfex (busulfan)3-12-0210-29-03October 29, 2003 PS recommended return to routine monitoring for AEs in all populations.
Zyrtec (cetirizine)3-13-0210-29-03October 29, 2003 Committee recommended return to routine monitoring for AEs in all populations.
Cozaar (losartan)3-20-0210-29-03October 29, 2003 Committee recommended return to routine monitoring for AEs in all populations.
Nolvadex (tamoxifen)5-16-0210-29-03October 29, 2003 Committee recommended return to routine monitoring for AEs in all populations.
Accupril (quinapril)6-7-0210-29-03October 29, 2003 Committee recommended return to routine monitoring for AEs in all populations.
Serzone (nefazodone)6-27-0210-29-03February 2, 2004 For additional information regarding PS recommendations and outcomes for SSRIs see Zoloft (sertraline HCl).
Paxil (paroxetine)6-27-022-3-04February 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)7-10-022-3-04February 3, 2004 PS recommended return to routine monitoring for AEs in all populations.
Celexa (citalopram)7-12-022-3-04February 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, 2005, label revised;
November 16, 2006 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)8-15-022-3-04February 3, 2004 PS recommended return to routine monitoring for AEs in all populations.
Hycamtin (topotecan)11-20-026-9-04June 9, 2004 PS recommended return to routine monitoring for AEs in all populations.
Temodar (temozolomide)11-20-026-9-04June 9, 2004 PS recommended return to routine monitoring for AEs in all populations.
Effexor (venlafaxine)12-2-026-9-04February 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 revision.
Vigamox (moxifloxacin)1-10-036-9-04June 9, 2004 PS recommended return to routine monitoring for AEs in all populations.
Ciloxan (ciprofloxacin)1-10-036-9-04June 9, 2004 Committee recommended return to routine monitoring for AEs in all populations.
Monopril (fosinopril)1-27-036-9-04June 9, 2004 PS recommended return to routine monitoring for AEs in all populations.
Allegra (fexofenadine)1-27-036-9-04June 9, 2004 PS recommended return to routine monitoring for AEs in all populations.
Duragesic (fentanyl)1-29-036-9-04June 9, 2004 The 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 label
View Duragesic MedGuide
Pulmicort/Rhinocort (budesonide)11-12-029-15-04September 15, 2004 The 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)2-12-039-15-04September 15, 2004 Committee recommended return to routine monitoring for AEs in all populations.
Cutivate/Flonase/Flovent (fluticasone),
Advair (fluticasone and salmeterol)
2-25-039-15-04September 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)3-12-039-15-04September 15, 2004 Committee recommended return to routine monitoring for AEs in all populations.
Fludara (fludarabine)4-03-039-15-04September 15, 2004 Committee recommended return to routine monitoring for AEs in all populations.
Fosamax (alendronate)4-28-039-15-04September 15, 2004 Committee recommended return to routine monitoring for AEs in all populations.
Lotensin (benazepril)7-2-032-14-05February 14, 2005 The Committee recommended continued close monitoring of benazepril in the pediatric population for future review.
March 25, 2008 Committee recommended return to routine monitoring for AEs in all population
Malarone (atovaquone/proguanil)8-6-032-14-05February 14, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Brevibloc (esmolol)8-22-032-14-05February 14, 2005 Committee recommended to continue monitoring and provide future review.
March 25, 2008 Committee recommended return to routine monitoring for AEs in all populations.
Viracept (nelfinavir)9-4-032-14-05February 14, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Xenical (orlistat)9-12-032-14-05February 14, 2005 PAC recommended continued monitoring and future review for the risk of cholelithiasis;
April 11, 2007
The PAC recommended return to routine monitoring for AEs in all populations.
Glucovance (glyburide/metformin)10-8-032-14-05February 14, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Arava (leflunomide)11-10-036-30-05June 30, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Concerta (methylphenidate)12-4-036-30-05June 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 label 
For additional information on ADHD products see Aderall XR March 22, 2006 meeting.
June 27, 2008,
revised label.
Zemplar (paricalcitol)12-8-036-30-05June 30, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Zomig (zolmitriptan)12-18-036-30-05June 30, 2005 Committee recommended return to routine monitoring for AEs in all populations.
 
Ortho-Tri-Cyclen (ethinyl estradiol; norgestimate)12-18-036-30-05June 30, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Cipro (ciprofloxacin)12-18-036-30-05June 30, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Trusopt (dorzolamide)1-5-046-30-05June 30, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Detrol;Detrol LA (tolterodine)1-5-046-30-05June 30, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Agrylin (anagrelide)5-24-0411-18-05November 18, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Paraplatin (carboplatin)4-30-0411-18-05November 18, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Diflucan (fluconazole)1-21-0411-18-05November 18, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Camptosar (irinotecan)3-10-0411-18-05November 18, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Tamiflu (oseltamivir phosphate)3-22-0411-18-05November 18, 2005 PAC requested follow-up within 2 years on neuropsychiatric (NP) and behavioral events. Label revised on November 13, 2006.
November 16, 2006 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;
November 27, 2007 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. Labeling.
January 17, 2008, revised label. 
Vioxx (rofecoxib)2-18-0411-18-05November 18, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Ferrlecit (sodium ferric gluconate complex in sucrose injection)3-24-0411-18-05November 18, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Imitrex (sumatriptan)2-18-0411-18-05November 18, 2005 Committee recommended return to routine monitoring for AEs in all populations.
Avapro (irbesartan)9-16-043-22-06March 22, 2006 Committee recommended return to routine monitoring for AEs in all populations.
Clolar (clofarabine)3-30-043-22-06March 22, 2006 Committee recommended return to routine monitoring for AEs in all populations.
Adderall XR (dextroamphetamine saccharate, amphetamine aspirate monohydrate, dextroamphetamine sulfate, amphetamine sulfate)10-28-043-22-06March 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 label.
May 22, 2007, revised label.
Meridia (sibutramine hydrochloride monohydrate)10-06-043-22-06March 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)11-17-0411-16-06November 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 label
Zofran (ondansetron)12-01-0411-16-06November 16, 2006 Committee recommended return to routine monitoring for AEs in all populations.
Avandia (rosiglitazone)12-09-0411-16-06November 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)01-27-0511-16-06November 16, 2006 Committee recommended return to routine monitoring for AEs in all populations.
Invanz (ertapenem)02-11-0511-16-06November 16, 2006 Committee recommended return to routine monitoring for AEs in all populations.
Zyvox (linezolid)02-11-0511-16-06November 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.
November 18, 2008 Committee accepted the follow-up report that revealed no new safety signals, but requested to see the completed QT report.
Trileptal (oxcabazepine)03-02-0511-16-06November 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.
March 8, 2008 Preliminary review of pediatric subpopulation.  Further evaluation of entire of adult and pediatric populations pending.
Mobic (meloxicam)04-15-0511-16-06November 16, 2006 Committee recommended return to routine monitoring for AEs in all populations.
Novolog (insulin aspart recombinant)05-24-0511-16-06November 16, 2006 Committee recommended return to routine monitoring for AEs in all populations.
Amaryl (glimepiride)06-09-0511-16-06November 16, 2006 Committee recommended return to routine monitoring for AEs in all populations.
Norvir (ritonavir)06-14-0511-16-06November 16, 2006 Committee recommended return to routine monitoring for AEs in all populations.
Lescol (fluvastatin)12-15-20054-11-07April 11, 2007 Recommended routine monitoring for AEs in all populations.
Sandostatin (octreotide)1-12-20064-11-07April 11, 2007 The 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. 
November 18, 2008 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.
January 25, 2010, revised label.
Serevent (salmeterol)3-09-0611-28-07November 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 indication.
Provigil (modafinil)3-21-0611-28-07November 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. Labeling change made October 21, 2010.
Emtrivia (emtricitabine)5-24-0611-28-07November 28, 2007 Committee recommended return to routine monitoring for AEs in all populations.
Gleevec (imatinib mesylate)6-09-0611-28-07November 28, 2007 Committee recommended return to routine monitoring for AEs in all populations.
Azopt (Brinzolamide)6-28-0611-28-07November 28, 2007 Committee recommended return to routine monitoring for AEs in all populations.
Betaxon (levobetaxolol)6-28-0611-28-07November 28, 2007 No recommendations. This drug is not marketed.
Toprol XL (metoprolol)7-27-063-25-08March 25, 2008 Committee recommended return to routine monitoring for AEs in all populations.
Celebrex (celecoxib)8-23-063-25-08March 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)8-23-063-25-08March 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)9-13-063-25-08March 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.
June 21, 2010, 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)9-27-063-25-08March 25, 2008 Committee recommended return to routine monitoring for AEs in all populations.
Coreg (carvedilol)11-8-063-25-08March 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)11-20-0611-18-08November 18, 2008 Committee recommended that FDA continue its standard, ongoing safety monitoring.
Lamisil (terbinafine)12-4-0611-18-08November 18, 2008 Committee recommended that FDA continue its standard, ongoing safety monitoring. 
Aldara (imiquimod)12-13-0611-18-08November 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.
The labeling change was made Oct. 13, 2010.
Zyprexa (olanzapine)1-10-0711-18-08November 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 requests. The committee agreed with the labeling change proposed by the Division.  The labeling was changed January 27, 2010. 
June 21, 2011, revised label
Lamictal (lamotrigine)2-14-0711-18-08November 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 label.
Risperdal (risperidone)2-28-0711-18-08November 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 requests101. 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)2-28-0711-18-08November 18, 2008 Committee recommended that FDA return to routine  monitoring for AEs 
Timolol GFS (timolol)2-28-0711-18-08November 18, 2008 Committee recommended that FDA return to routine monitoring for AEs 
Levaquin (levofloxacin)3-14-0711-18-08November 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.
DrugPediatric Labeling Date*

 

Date Reported to
Advisory Committee
 

 

Pediatric Advisory Committee Recommendations and
Subsequent Outcomes

* PAC Reviews triggered by the Pediatric Labeling Date

 

Combigan (brimonidine/timolol)10-30-076-23-09June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Derma-Smoothe/FS (fluocinolone acetonide)12-12-076-23-09June 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)12-19-076-23-09June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Inspra (eplerenone)1-31-086-23-09June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Moxatag (amoxicillin)1-23-086-23-09June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Alvesco (ciclesonide)1-10-086-23-09June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Omnaris (ciclesonide)11-21-07
 
6-23-09June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs
Zometa (zoledronic acid)3-20-086-23-09June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Diovan (valsartan)11-29-076-23-09June 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)2-1-086-23-09June 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.
Labeling changed Sept. 17, 2010.
AndroGel (testosterone)12-27-076-23-09June 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 label
Depakote (divalproex sodium)3-24-086-23-09June 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)6-5-0812-08-09December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Aptivus (tipranavir)6-23-0812-08-09December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Reyataz (atazanavir Sulfate)3-25-08
 
12-08-09December 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)11-9-07
6-20-08
12-08-09December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
September 22, 2011 - Committee was given an informational update.
December 2011,revised label
Argatroban (argatroban)5-5-0812-08-09December 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)12-27-0712-08-09December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Evicel [fibrin sealant (human)]1-2-0812-08-09December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Artiss [fibrin sealant (human)]3-19-0812-08-09December 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)7-29-0812-08-09December 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 label.
Ventolin HFA (albuterol)3-26-0812-08-09December 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)4-7-0812-08-09December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Humira (adalimumab)2-21-0812-08-09December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Abilify (aripiprazole)10-29-07
2-27-08
 
12-08-09December 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 403-31-083-22-10March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Cardiolite (technetium Tc99m)4-30-083-22-10March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Nasacort AQ (triamcinolone)9-19-083-22-10March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Viramune (nevirapine)6-24-083-22-10March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Daptacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)3-12-083-22-10March 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)6-24-083-22-10March 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)6-20-083-22-10March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.   
Rotarix (Rotavirus Vaccine, Live, Oral)4-3-083-22-10March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Valtrex (valacyclovir)9-3-083-22-10March 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)10-8-083-22-10March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.   
Casodex (bicalutamide)12-19-086-21-10June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Apidra (insulin glulisine recombinant)10-24-086-21-10June 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))3-14-086-21-10June 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)12-5-086-21-10June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Desmopressin Acetate5-8-086-21-10June 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)10-28-086-21-10June 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)2-27-08
6-18-09
 
6-21-10June 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)6-30-086-21-10June 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)3-20-086-21-10June 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)5-9-086-21-10June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Zemuron (rocuronium)8-28-086-21-10June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Kogenate FS (antihemophilic factor (recombinant))10-10-086-21-10June 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)10-21-0812-7-10December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Ulesfia Lotion 5% (benzl alcohol)4-9-0912-7-10December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Epiduo Gel (adapalene & benzoyl peroxide)12-17-0812-7-10December 7, 2010 Committee recommended to revise the label to include potential for patient hypersensitivity to the product and a follow-up after label revision. Label revised Feburary 18, 2011.
Gardasil 159 [Human Papillomavirus Quadrivalent (types 6, 11, 16, 18) vaccine recombinant] 9-12-08
 
12-7-10December 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)8-21-0912-7-10December 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)7-1-0812-7-10December 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)11-14-0812-7-10December 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)12-18-08
 
12-7-10December 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)12-11-0812-7-10December 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)1664-30-0912-7-10December 7, 2010   Committee recommended return to standard, ongoing monitoring for adverse events.
Lamictal XR (lamotrigine)5-29-09
1-29-10
 
12-7-10December 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)5-8-0912-7-10December 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)8-19-095-16-11May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Bepreve (bepotastine besilate)9-8-095-16-11May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Besivance (besifloxacin)5-28-095-16-11May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Cetraxal (ciprofloxacin otic)5-1-095-16-11May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Patanase Spray (olopatadine hydrochloride)4-15-08
12-1-09
5-16-11May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Astepro spray(azelastine hydrocholoride)8-31-095-16-11May 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)10-15-095-16-11May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Welchol (colesevelam)10-2-095-16-11May 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)9-2-09
 
5-16-11May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Lexapro (escitalopram oxalate)3-19-095-16-11May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Actonel (risedronate)7-23-095-16-11May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Valcyte (valganciclovir)8-28-095-16-11May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Retrovir (zidovudine)9-19-08
11-6-09
9-22-11September 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.
Ziagen (abacavir)12-19-089-22-11September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Topamax (topiramate)12-22-09
 
9-22-11September 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.
Navstel Intraocular Irrigating Solution Sterile (balanced salt ophthalmic solution with hypromellose, dextrose & glutathione)7-24-089-22-11September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Akten Ophthalmic (lidocaine hydrochloride ophthalmic gel 3.5%)10-7-089-22-11September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Triesence (trimcinolone acetonide injectable suspension)11-29-079-22-11September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Melody Transcatheter Pulmonary Valve and Ensemble Delivery System1-25-109-22-11September 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 vaccine10-19-099-22-11September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
AFLURIA Infuenza virus vaccine11-10-09 9-22-11September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Famvir (famciclovir)12-24-09
 
9-22-11September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Videx EC (didanosine)9-29-089-22-11September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Abilify (aripiprazole)11-19-099-22-11September 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 label
Zomig Nasal Spray(zolmitriptan)10-14-089-22-11September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Levaquin (levofloxacin)5-5-089-22-11September 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)12-23-091-30-12January 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)12-14-09
6-29-10
1-30-12January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Seroquel (quetiapine fumarate)12-2-091-30-12January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.   
Xolair (omalizumab)1-4-101-30-12January 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)7-10-091-30-12January 30, 2012 – Committee recommended return to standard, ongoing monitoring for adverse events.
Flomax (tamsulosin hydrochloride)12-22-091-30-12January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Atacand (candesartan cilexetil)10-22-091-30-12January 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)2-4-101-30-12January 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 revised.
Pancreaze (pancrelipase)4-12-101-30-12January 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)8-27-09
 
1-30-12January 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)4-30-09
 
1-30-12January 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)7-31-091-30-12January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Mirena (levonorgestrel – releasing intrauterine system)10-1-091-30-12January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Prevnar 13 [pneumococcal 13-valent conjugate vaccine (diptheria CRM197 protein)]2-24-101-30-12January 31, 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)10-16-09
7-19-11
1-30-12January 31, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Tamiflu (oseltamivir phosphate)2-22-105-7-12May 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)3-24-105-7-12May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Differin (adapalene)3-17-105-7-12May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee requested an update after the review is completed.
MultiHance (gadobenate dimeglumine)3-17-105-7-12May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Dulera (formoterol fumarate; mometasone furoate)6-22-105-7-12May 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 5-11 year olds are completed.
Nasonex (mometasone furoate monohydrate)5-26-10
1-19-11
5-7-12May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Taxotere (docetaxel)5-13-105-7-12May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Omnaris (ciclesonide)5-7-105-7-12May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Natazia (dienogest; estradiol valerate)5-6-105-7-12May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Protonix (pantoprazole sodium)11-12-095-7-12May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
MENVEO Meningococcal (Groups A,C,Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine2-19-10
1-28-11
5-7-12May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine Recombinant10-16-09
12-22-10
5-7-12May 7, 2010 -741 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)5-18-105-7-12May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Zylet (loteprednol etabonate and tibramycin)6-3-105-7-12May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Isopto Carpine (pilocarpine hydrochloride6-22-105-7-12May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
9-28-109-11-12September 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.
11-10-109-11-12September 11, 2012 - Committee recommended t return to standard, ongoing monitoring for adverse events and to be notified after class labeling for ADHD medications is completed.
9-24-109-11-12
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.
8-13-109-11-12September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
10-21-109-11-12September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
10-29-109-11-12September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
11-2-109-11-12September 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.
7-28-109-11-12September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
10-5-109-11-12September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
8-27-109-11-12September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
mandated annual review
1-25-109-11-12September 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)3-10-119-11-12

September 11, 2012 - Committee agreed that the HDE device is appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.

4-22-113-14-13

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 Globulin Subcutaneous (Human) 20% Liquid2-17-113-14-13March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events. More utilization information is needed for the CBER products.
ALIMTA (pemetrexed disodium)3-17-113-14-13March 14, 2013 - Committee recommended return to ongoing monitoring for adverse events.
GADAVIST (gadobutrol) 3-14-113-14-13March 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)6-1-113-14-13March 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)1-18-113-14-13March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events.
UROXATRAL (alfuzosin hydrochloride)12-15-103-14-13March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events.
CREON (pancrelipase)6-10-113-14-13March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events.
ZENPEP (pancrelipase)6-15-113-14-13March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events.
MOXEZA (moxifloxacin ophthalmic solution 0.5%)11-19-103-14-13March 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)4-29-113-14-13March 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
12-15-11 & 4-29-113-14-13March 14, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee requested labeling changes in the indications section.
INOMAX (nitric oxide)12-21-103-14-13March 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.
4-15-113-14-13March 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.
4-25-113-14-13March 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.
4-6-113-14-13
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, Recombinant7-19-119-19/20-13September 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)11-9-119-19/20-13September 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)8-22-119-19/20-13September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events. 
Faslodex (fulvestrant)5-17-119-19/20-13September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events. 
Gammagard Liquid, [Immune Globulin Infusion (Human)] 10%7-22-119-19/20-13September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.
HEMACORD (hematopoietic progenitor cell, cord blood)11-10-119-19/20-13September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events. 
Intuniv (guanfacine)7-28-109-19/20-13September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.   
Isentress (raltegravir)12-21-119-19/20-13September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.   
Ixempra Kit (ixabepilone)10-18-119-19/20-13September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.   
Plavix (clopidogrel bisulfate)5-6-119-19/20-13September 19-20, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events.   
Topamax (topiramate)7-15-119-19/20-13
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 Device12-16-119-19/20-13September 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) mandated annual review3-10-119-19/20-13September 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 Therapy mandated annual review1-25-109-19/20-13September 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.

**From April 1999-June 2004, this committee was a subcommittee of the Anti-Infective Drugs Advisory Committee.