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Antidepressant "Black Box" Warning On Suicidality Risk Recommended By Joint Cmte.

A "black box" warning on the risk of suicidality in pediatric patients should be added to antidepressant drug labeling, a joint FDA advisory committee concluded.

The black box warning "won't make prescribing [in children] more difficult," Psychopharmacologic Drugs Advisory Committee Chair Wayne Goodman, MD, University of Florida McKnight Brain Institute, maintained. However, he added, "I anticipate there will be alarm from parents and the child."

"I think that it is worth that complication because it will raise the threshold to prescribing and force an engagement of a discussion not only about the risk but the potential benefits and alternatives to medication," Goodman said.

The committee members and consultants voted 15 to eight in favor of a black box warning.

Voting consultant Matthew Rudorfer, MD, National Institute of Mental Health, opposed the black box. "I believe that while we're concerned about a 2%-3% increase of risk of suicidality, I think the underlying illness carries a 15% risk of suicide if left untreated and I fear that the black box will impede access to treatments," he said.

"I think the appropriate warnings could be conveyed in bolded language that would more likely both be appreciated by prescribers without scaring off patients and families and clinicians," Rudorfer added.

FDA's psychopharm committee and new Pediatric Advisory Committee met for two days to review re-analyzed and re-classified data initially presented at a February meeting held by FDA.

Direct-to-consumer advertising for antidepressants will likely be affected if FDA follows the committee recommendation to add a black box warning.

"An incidental consequence of that is that products that carry box warnings also have to carry that in their advertising and quite frequently that makes it quite difficult to explicitly advertise that product in direct-to-consumer advertising," Office of Drug Safety Deputy Director Anne Trontell, MD/MPH, said.

"You can't use reminder ads either," Office of Drug Evaluation I Director Robert Temple, MD, added.

The box warning should include information on suicidal behavior risk as well as note lack of efficacy seen in antidepressants not approved for any use in the pediatric population, committee members said. Lilly's Prozac (fluoxetine) is the only antidepressant approved for treatment of children with major depressive disorder.

A patient medication guide was also recommended by the committees as a way to convey information to pediatric patients and their parents.

The committee members agreed that a contraindication for antidepressants against use in children was unnecessary and would withhold potentially beneficial therapy from pediatric patients.

The committee members and consultants voted unanimously that the suicidality signal seen in the studies reviewed could be generalized across all of the antidepressant drugs studied.

Any warning should be considered class labeling rather than lead to different labeling for each antidepressant based on the specific risk shown in the studies with the particular drug, the committees said.

"It is premature to identify a drug that should be exempted from this warning," Goodman said.

The committees further agreed that any warning of suicidal behavior risk should be applied to older antidepressants not included in the studies and any new agents approved by FDA.

That would mean Lilly's recently approved serotonin and norepinephrine reuptake inhibitor Cymbalta (duloxetine) would be required to carry the same boxed warning. Cymbalta was approved for major depressive disorder Aug. 3 and received an indication for diabetic neuropathic pain one month later.

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Posted: Tuesday, September 14, 2004

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This meeting will be held September 13, 2004 at the Holiday Inn in Bethesda, Md. beginning at 8 a.m.
    Draft Agenda     Briefing Material     Briefing Addendum    
    Psychopharm Committee     Pediatric Committee            

  • Antidepressant Suicidality: Potential Class Risk Will Be Considered By Pediatric, Psychopharm Cmtes.   [Posted: 8/26/04]
  • FDA Analysis Of Antidepressant Pediatric Suicidality Data To Be Reviewed Sept. 13-14   [Posted: 8/3/04]

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