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Antidepressant Reports Of Suicidality In Children Will Be Topic Of FDA Cmte. Meeting In February

Reports of suicidal ideation and suicide attempts in pediatric patients receiving antidepressants for major depressive disorder will be discussed at a Feb. 2, 2004 joint meeting of FDA’s Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee.

The committee will review the reports of suicidality from clinical trials of antidepressants and consider optimal approaches to analysis of the data and what further research is needed to address questions on the topic.

The group was also to consider what regulatory action may be needed for clinical use of these products in pediatric patients. However, that discussion has been postponed to allow for further analysis of the data. FDA said it will schedule another meeting by summer 2004. 

In August, labeling for Wyeth’s Effexor (venalafaxine) was revised to add a precaution based on reports of hostility and suicide-related adverse events in pediatric clinical trials with the serotonin and norepinephrine reuptake inhibitor.

Wyeth submitted several Effexor studies in children and adolescents to FDA at its request. In pediatric patients treated with major depressive disorder, 2% of Effexor XR patients discontinued treatment due to hostility (versus <1% on placebo), and 2% stopped treatment as a result of suicidal ideation (versus 0% on placebo).

In children and adolescents with generalized anxiety disorder, 1% of Effexor patients discontinued treatment due to abnormal/changed behavior compared to zero patients on placebo. There were no suicides during the pediatric clinical trials.

Data from pediatric studies with Glaxo SmithKline’s Paxil (paroxetine) have also shown increases in suicidality. In a June "Talk Paper", FDA said that it was reviewing reports of a possible increased risk of suicidal thinking and suicide attempts in children and adolescents for the treatment of MDD with Paxil.

The data came from three well-controlled pediatric major depression studies that fulfilled the pediatric study requirement for Paxil CR as well as IR Paxil. FDA reported that the risk of suicidal events ‘was about three times greater with Paxil compared to placebo.’ Further, the studies ‘failed to show that the drug was more effective than placebo,’ FDA said.

The U.K.’s Medicines & Healthcare Products Regulatory Agency changed paroxetine (Seroxat in the U.K.) labeling June 10 to reflect its conclusion that 'the balance of risks and benefits of [paroxetine] is unfavorable when used to treat depressive illness in [children and adolescents under the age of 18].'

Lilly’s Prozac is approved for use in pediatric patients with major depressive and obsessive compulsive disorders. Pfizer’s Zoloft is indicated for pediatric patients with OCD and is "approvable" for pediatric depression. The drugs contain general warnings of suicide ideation associated with depression.

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, October 10, 2003

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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 Suicidality Event Classification Substantially Different Across Sponsor Programs, FDA Tells Cmte.   [Posted: 1/23/04]

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