MINUTES OF THE

PEDIATRIC ADVISORY COMMITTEE

 

Advisory Committee Conference Room, Room 1066

5630 Fishers Lane, Rockville, Maryland

 

Thursday, November 16th, 2006

 

The meeting was convened at approximately 8:15 a.m.

 

Members Present (voting) for November 16th, 2006

Robert Ward, M.D. (Acting Chair)

Avital Cnaan, Ph.D., M.S.

Robert S. Daum, M.D.

Deborah L. Dokken, M.P.A.

Leon Dure, M.D.

Melissa Maria Hudson, M.D.

Keith Kocis, M.D., M.S.

John W. M. Moore, M.D., M.P.H.

Thomas B. Newman, M.D., M.P.H.

 

Pediatric Advisory Committee Pediatric Health Organization Representative

Richard L. Gorman, M.D.

 

Pediatric Advisory Committee Industry Representative

Elizabeth A. Garofalo, M.D.

 

Executive Secretary

Carlos Peρa, Ph.D., M.S.

 

FDA Participants

Debra Birnkrant, M.D.

Marc Cavaillι-Coll, M.D., Ph.D.

Martin Cohen, M.D.

Felicia Collins, M.D., M.P.H., FAAP

Eileen Craig, M.D.

Linda Forsyth, M.D.

Mark Hirsch, M.D.

Rosemary Johann-Liang, M.D., FAAP

Lisa Jones, M.D.

Russell Katz, M.D.

Joyce Korvick, M.D.

Thomas Laughren, M.D.

Linda Lewis, M.D.

Iris Masucci, PharmD, BCPS

Lisa Mathis, M.D.

Evelyn Mentari, M.D., M.S.

Robert Misbin, M.D.

Andrew Mosholder, M.D., M.P.H.

Dianne Murphy, M.D., FAAP

Andreas Pikis, M.D.

Alan Shapiro, M.D., Ph.D., FAAP

Jeffrey Siegel, M.D.

Alfred Sorbello, D.O.

Jean Temeck, M.D.

Hui-Hsing Wong, M.D.

Joanna Zawadzki, M.D., FACP, FACE

 

Voting Consultants

Larry Sasich, Pharm.D., M.P.H., FASHP (Acting Consumer Representative)

Geoffrey L. Rosenthal, M.D., Ph.D.

 

Open Public Hearing Speakers

None

 

Presentations

Pediatric Advisory Committee: Overview of Role and Evolution of Process

Dianne Murphy, M.D., FAAP, Director, Office of Pediatric Therapeutics, OC

Committee Role in BPCA Safety Reviews

Rosemary Johann-Liang, MD, FAAP, Deputy Director, Division of Drug Risk Evaluation, CDER

One Year Post-Exclusivity Adverse Event Review: Zyvox (Linezolid)

Alan Shapiro, MD, PhD, FAAP, Medical Officer, Pediatric and Maternal Health Staff, CDER

One Year Post-Exclusivity Adverse Event Review: Avandia (Rosiglitazone)

Lisa Mathis, MD, Director, Pediatric and Maternal Health Staff, CDER

One Year Post-Exclusivity Adverse Event Review: Zofran (Ondansetron)

Felicia Collins, MD, MPH, FAAP, Medical Officer, Pediatric and Maternal Health Staff, CDER

One Year Post-Exclusivity Adverse Event Review: Celexa (Citalopram) – Safety Update

Lisa Mathis, MD

Review Update: QT Prolongation With Citalopram and Escitalopram

Lisa Jones, MD, Medical Officer, Division of Psychiatry Products, CDER                                                 

One Year Post-Exclusivity Adverse Event Review: Trileptal (Oxcarbazepine)

Felicia Collins, MD, MPH, FAAP

Suicidality and Antiepileptic Drugs:Status of Clinical Trial Data Analysis

Evelyn Mentari, MD, MS, Medical Officer, Division of Neurology Products, CDER

Tamiflu (Oseltamivir) – Safety Update

Rosemary Johann-Liang, MD, FAAP, Andrew Mosholder, MD, MPH, Epidemiologist, Division of Drug Risk Evaluation, CDER

Update on Current FDA Labeling Initiatives

Iris Masucci, PharmD, BCPS, CDER

One Year Post-Exclusivity Adverse Event Review: Norvir (Ritonavir)

Alan Shapiro, MD, PhD, FAAP, Medical Officer, Pediatric and Maternal Health Staff, CDER

One Year Post-Exclusivity Adverse Event Review: Rapamune (Sirolimus)

Alan Shapiro, MD, PhD, FAAP, Medical Officer, Pediatric and Maternal Health Staff, CDER

Abbreviated Presentations and Updates to Committee: Invanz (Ertapenem)

Alan Shapiro, MD, PhD, FAAP, Medical Officer, Pediatric and Maternal Health Staff, CDER

Abbreviated Presentations and Updates to Committee: Gemzar (Gemcitabine)

Alan Shapiro, MD, PhD, FAAP, Medical Officer, Pediatric and Maternal Health Staff, CDER

Abbreviated Presentations and Updates to Committee: Amaryl (Glimepiride)

Lisa Mathis, MD, Director, Pediatric and Maternal Health Staff, CDER

Abbreviated Presentations and Updates to Committee: Novolog (Insulin Aspart Recombinant)

Lisa Mathis, MD, Director, Pediatric and Maternal Health Staff, CDER

Abbreviated Presentations and Updates to Committee: Mobic (Meloxicam)

Lisa Mathis, MD, Director, Pediatric and Maternal Health Staff, CDER

Abbreviated Presentations and Updates to Committee: Ditropan (Oxbutynin) – Safety Update

Lisa Mathis, MD, Director, Pediatric and Maternal Health Staff, CDER

Abbreviated Presentations and Updates to Committee: Lipitor (Atorvastatin) – Safety Update

Jean Temeck, MD, Medical Officer, Pediatric and Maternal Health Staff, CDER

Abbreviated Presentations and Updates to Committee: Zocor (Simvastatin) – Safety Update

Jean Temeck, MD, Medical Officer, Pediatric and Maternal Health Staff, CDER

 

Sponsor Presentations

None

 

Summary of Committee Discussions and Recommendations

One Year Post-Exclusivity Adverse Event Review: Zyvox (Linezolid)

Committee Recommendations –

  • Recommend routine monitoring for Adverse Events (AEs) in all populations; and
  • Committee agreed with the commitment to provide a follow-up report on the cardiac events from the Office of Safety and Epidemiology (OSE) conducting a review for patients of all ages.

Committee Vote –

  • All panel members concurred.

 

One Year Post-Exclusivity Adverse Event Review: Celexa (Citalopram) – Safety Update

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations; and
  • Requested to receive/hear the results of the division’s review of the company’s QT analysis which they thought would be more useful than additional reviews of Adverse Event Reporting System (AERS).

Committee Vote –

  • All panel members concurred.

                                               

One Year Post-Exclusivity Adverse Event Review: Trileptal (Oxcarbazepine)

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations; and
  • Committee made this 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.

Committee Vote –

  • All panel members concurred.

 

Tamiflu (Oseltamivir) – Safety Update

Committee Recommendations –

  • Concurred with previous Pediatric Advisory Committee Request for an extensive analysis of the neuropsychiatric/behavioral events at the Fall/Winter 2007 Pediatric Advisory Committee Meeting;
  • Requested FDA inquire of Roche or the Japanese if they had data on the extent of use that is for prophylaxis and the possibility of looking as this population for a comparator regarding neuropsychiatric/behavioral AE’s.
  • A number of Committee members believed the new labeling, in one area, was not strong enough. In contrast to the present label, which instructs the parent to consult the physician or health care provider if any of the concerning behaviors occur, they thought it should advise the parent to stop the medication and contact the physician or health care provider.  They asked the division to consider this but did not take a vote or insist; and

·         One Committee member expressed concern about the label recommending against treatment of infants less than one year of age due to their high mortality from influenza, but no vote was taken concerning this issue.

Committee Vote –

  • All panel members concurred on bullet 1.

 

One Year Post-Exclusivity Adverse Event Review: Avandia (Rosiglitazone)

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations; and
  • Committee agreed that the wording in the main text of the label concerning lack of efficacy of the pediatric trials should also be placed in the patient information part of the label, which presently has a statement that is not useful.

Committee Vote –

  • All panel members concurred.

 

One Year Post-Exclusivity Adverse Event Review: Zofran (Ondansetron)

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations.

Committee Vote –

  • All panel members concurred.

 

One Year Post-Exclusivity Adverse Event Review: Norvir (Ritonavir)

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations.

Committee Vote –

  • All panel members concurred.

 

One Year Post-Exclusivity Adverse Event Review: Rapamune (Sirolimus)

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations; and
  • Committee requested to be informed (email was adequate) about the outcome of discussions with the Sponsor about potential labeling changes concerning pericarditis.

Committee Vote –

  • All panel members concurred.

 

One Year Post-Exclusivity Adverse Event Review: Invanz (Ertapenem)

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations.

Committee Vote –

  • All panel members concurred.

 

Abbreviated Presentations and Updates to Committee: Gemzar (Gemcitabine)

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations.

Committee Vote –

  • All panel members concurred.

 

Abbreviated Presentations and Updates to Committee: Amaryl (Glimepiride)

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations.

Committee Vote –

  • All panel members concurred.

 

Abbreviated Presentations and Updates to Committee: Novolog (Insulin Aspart Recombinant)

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations.

Committee Vote –

  • All panel members concurred.

 

Abbreviated Presentations and Updates to Committee: Mobic (Meloxicam)

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations.

Committee Vote –

  • All panel members concurred.

 

Abbreviated Presentations and Updates to Committee: Ditropan (Oxbutynin) – Safety Update

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations.

Committee Vote –

  • All panel members concurred.

 

Abbreviated Presentations and Updates to Committee: Lipitor (Atorvastatin) – Safety Update

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations.

Committee Vote –

  • All panel members concurred.

 

Abbreviated Presentations and Updates to Committee: Zocor (Simvastatin) – Safety Update

Committee Recommendations –

  • Recommend routine monitoring for AEs in all populations.

Committee Vote –

  • All panel members concurred.

 

Additional Committee Recommendations –

  • In response to the update on current FDA labeling initiatives, the committee recommended the following:
    • The Committee recommended it would be helpful to have pediatric information for approved indications placed in the label in the usual places and information related to an unapproved use in the Pediatrics Use section;
    • The Committee recommended labeling should distinguish the difference between the lack of a study for approval and the lack of efficacy to support approval in the Pediatric Use Section; and
    • The Committee recommended the Indications and Usage section should state the approved patient population.
  • Committee agreed to FDA providing a more abbreviated (1 slide with the list of products and an opportunity for comment) presentation of products which have been reviewed by FDA and have no safety or other concerns. They would still receive all of the background materials.

 

 

 

 


The meeting adjourned at approximately 4:15 p.m.

 

Please see transcript for details

 

I certify that I attended the November 16, 2006 meeting of the Pediatric Advisory Committee and that these minutes accurately reflect what transpired.

 

 

 

 


                    //S//                     .             

Carlos Peρa, Ph.D., M.S.

Executive Secretary

 

 

 

 

 

 

 

                    //S//                     .             

Robert Ward, M.D.

Acting Chair