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Antidepressant Strengthened Warnings About Pediatric Suicidality Risk Needed Immediately, Cmte. Says

Strengthened warnings about the risk of suicide ideation and attempts with antidepressant medications in children should be communicated to physicians and consumers as soon as possible, a joint FDA advisory committee told the agency Feb. 2.

The warnings should be issued about the possible risk of suicidal behavior with antidepressants at the same time as FDA proceeds with a re-analysis of pediatric data from manufacturers to verify whether a signal seen with the drugs has a more definitive association, members of the joint committee said.

Warnings are needed in the interim to "elevate the level of concern and attention that practitioners use in prescribing" antidepressant medications, Psychopharmacologic Drugs Advisory Committee Chair Matthew Rudorfer, MD, National Institute of Mental Health, explained. The Psychopharm committee met with the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee.

"We want to put a speed bump in the road," Rudorfer said, so that the psychiatrists and non-psychiatric physicians who are prescribing antidepressants "take the medications more seriously."

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

Lilly's Prozac (fluoxetine) has not been associated with a similar signal and is the only selective serotonin inhibitor to be indicated for pediatric major depressive disorder. Pediatric studies for the other SSRIs have been negative or inconclusive concerning efficacy for depression in children. 

FDA wants to further analyze the safety data after events reported from the manufacturers have been reclassified for suicidal behavior by an outside expert panel assembled by Columbia University.

Members of the FDA’s advisory committee said that the panel should not only look at suicidal behavior but also evidence of "activation" in patients on the drugs. Indications of activation could include increased agitation, aggression, akathisia (uncontrollable limb and body movements), confusion, and violence toward others.

The committee heard from 65 speakers during the meeting's public hearing, many of whom were parents of children who had committed or attempted suicide or homicide after a short time on antidepressants. Many described severe behavioral changes in their children.

FDA expects to re-analyze the data by this summer and hold another advisory committee to discuss more definitive regulatory actions for the antidepressant class.

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Posted: Tuesday, February 03, 2004

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    Briefing Information     Psychopharm Committee     Pediatric Subcommittee    

  • Antidepressant Suicidality Event Classification Substantially Different Across Sponsor Programs, FDA Tells Cmte.   [Posted: 1/23/04]
  • Antidepressant Reports Of Suicidality In Children Will Be Topic Of FDA Cmte. Meeting In February   [Posted: 10/10/03]

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