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Antidepressant Suicidality Event Classification Substantially Different Across Sponsor Programs, FDA Tells Cmte.

How to classify possibly suicide-related events in pediatric patients receiving antidepressant drugs will be one topic for FDA's advisory committees at a Feb. 2 meeting.

"We would welcome any advice the committees might have on how to classify these events for the purpose of further analysis," FDA said in briefing materials for its Psychopharmacologic Drugs Advisory Committee and Anti-Infective Drugs Advisory Committee/Pediatric Subcommittee.

"The approach used by sponsors thus far has been to classify cases first into a crude category of ‘possibly suicide-related’, and then a further subgrouping of that broader group into a ‘suicide attempt’ class," FDA noted, adding that there were "substantial differences across different programs in the selection of cases representing suicide attempts."

The discussion will be an important one since FDA has asked Columbia University to coordinate a review of pediatric antidepressant suicidal event data. "It would be desirable to have potential events blindly reclassified by an independent group," FDA said.

A contract with Columbia University is in place "for having this reclassification of cases accomplished and also to work out the details of a standard approach to both finding all relevant cases and setting up categories for the reclassification effort that would meet our needs from a regulatory standpoint," FDA said.

"We expect it will take at least another several months to complete this reclassification effort," the agency said. The Columbia University group will make a presentation at the Feb. 2 meeting.

The committee will also be asked "how one might develop guidance for more adequate assessment for emergent suicidality in future studies" and advice on "possible modifications to the search strategies used for identifying cases that might have been missed."

The meeting follows a FDA public health advisory in October alerting health care professionals "to reports of the occurrence of clinical trials for various antidepressant drugs in pediatric patients".

The recommendation was an extension of a June notice warning that GlaxoSmithKline’s Paxil (paroxetine) "not be used in the treatment of pediatric" major depressive disorder because of reports of suicide-related behavior.

FDA’s preliminary review of summary data provided by sponsors revealed a signal of increased risk of suicidality for paroxetine, sertraline (Pfizer’s Zoloft), venlafaxine (Wyeth’s Effexor), and citalopram (Forest’s Celexa).

"We are not yet confident in what the identified events represent," FDA said. "The signals for the most part were coming from a single trial within each of these programs."

To watch a live or archived webcast of this meeting, click the button below. To arrange for live videoconferencing or to order videotapes & CDs, email or call 800-627-8171.

Posted: Friday, January 23, 2004

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This meeting will be held February 2, 2004 at the Holiday Inn in Bethesda, Md. beginning at 8 a.m.
    Briefing Information     Psychopharm Committee     Pediatric Subcommittee    

  • Antidepressant Strengthened Warnings About Pediatric Suicidality Risk Needed Immediately, Cmte. Says   [Posted: 2/3/04]
  • Antidepressant Reports Of Suicidality In Children Will Be Topic Of FDA Cmte. Meeting In February   [Posted: 10/10/03]

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