advertising_left.gif     advertising_right.gif
"The Pink Sheet"
"The Tan Sheet"
Health News Daily


Allergenic Products
Anesthetic and Life Support Drugs
Anti-Infective Drugs
   Pediatric Subcommittee
Antiviral Drugs
   Immunosuppressive Drugs
Arthritis Drugs
Biological Response Modifiers
Blood Products
Cardiovascular and Renal Drugs
Dermatologic and Ophthalmic Drugs
Device Panels
Drug Safety and Risk Mgmt
   Drug Abuse
Endocrinologic and Metabolic Drugs
Gastrointestinal Drugs
Medical Imaging Drugs
Nonprescription Drugs
Oncologic Drugs
   Ethics Subcmte.
Peripheral and Central Nervous System Drugs
Pharmaceutical Science
   Nonclinical Studies
   Clinical Pharmacology
   Orally Inhaled & Nasal Drug Products
Pharmacy Compounding
Psychopharmacologic Drugs
Public Meetings
Pulmonary-Allergy Drugs
Reproductive Health Drugs
Science Board
Transmissible Spongiform Encephalopathies
Vaccines and Related Biological Products

FDA Analysis Of Antidepressant Pediatric Suicidality Data To Be Reviewed Sept. 13-14
FDA’s analysis of independently reviewed pediatric suicidality data for antidepressants will be discussed Sept. 13 & 14 during a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the newly formed Pediatric Advisory Committee.
The meeting is being held as a follow-up to a Feb. 2 meeting where advisory committee members expressed concern about the high degree of variability and lack of categorization of events believed to be suicide related.
FDA’s preliminary review of over 4,000 pediatric patients from clinical trials of several antidepressants identified 109 cases as “possibly suicide related.”
Since the Feb. 2 meeting, “experts in pediatric suicidality, assembled by Columbia University, have independently classified these reported events, and FDA has conducted an analysis of these data,” a Federal Register notice slated for publication Aug. 4 states.
The Columbia group employed a standardized methodology to categorize events into “suicidal,” “non-suicidal,” and “indeterminate.” The suicidal category has three subdivisions: “suicide attempt,” “suicidal ideation,” and “suicidal behavior without injury.”
“The committees will consider the results of FDA’s analysis of these independently classified events and will consider what further regulatory action may be needed with regard to the clinical use of these products in pediatric patients,” the Federal Register notice reports.
Also on the agenda for the two-day meeting is discussion of further research needed to address questions of pediatric suicidality with antidepressant use.
FDA’s conduct with regard to the pediatric data remains under investigation by the Senate Finance Committee. The investigation was recently expanded with an inquiry regarding the relationship between CDER’s Office of New Drugs and Office of Drug Safety.
In the wake of the investigation, eight out of 10 of the selective serotonin reuptake inhibitors have added class warnings on suicidality to labeling. Pfizer is negotiating language for Zoloft; Solvay’s Luvox was withdrawn in 2002.
The Sept. 13-14 meeting will be the first meeting of the full Pediatric Advisory Committee. The Pediatric Ethics Subcommittee will meet Sept. 10 to discuss a study protocol for dextroamphetamine; a full committee review will follow Sept. 15.
To watch a webcast of this meeting, click the button below. To arrange for live videoconferencing, or to order videotapes & DVDs, email or call 800-627-8171.
Posted: Tuesday, August 03, 2004

Sign up to view this meeting.
This meeting will be held September 13, 2004 at the Holiday Inn in Bethesda, Md. beginning at 8 a.m.


The latest FDA Advisory Committee news and information delivered directly to your email box.


Copyright and Privacy Policy