FDA Advisory Committee Votes to Warn of Antidepressant Risks

The FDA advisory committee voted to recommend "black box" warnings on antidepressant prescription labels, warning physicians and patients of the increased risk of suicidal thoughts in children and teenagers. The committee also agreed that pharmaceutical manufacturers should provide patient guides to the drugs' packaging describing the risks of suicide in plain language. Hundreds of approved drugs have black-box warnings, but fewer than 30 are required to have such patient attachments.

Key Takeaways:

• The FDA advisory committee voted 15 to 8 to recommend "black box" warnings on antidepressant prescription labels to warn of the increased risk of suicidal thoughts in children and teenagers.
• The committee also agreed that pharmaceutical manufacturers should provide patient guides to the drugs' packaging describing the risks of suicide in plain language.
• Children and teenagers who take antidepressants are twice as likely as those given placebos to become suicidal, according to studies presented to the committee.
• The risk of suicide is low, with 2 or 3 more patients becoming suicidal for every 100 given the drugs compared to those given placebos.
• Most antidepressants have failed to cure depression in teenagers and children, with some studies showing no benefit.
• Pfizer's antidepressant Zoloft is prescribed to youngsters more often than any other antidepressant, despite failing in two tests to prove its effectiveness in treating depressed teenagers and children.
• The FDA is not required to follow the advice of its advisory committees, but it usually does.
• Critics of the drugs argued that the benefits of the medications are unclear at best, with some committee members saying that any risk was "all but unacceptable."
• The FDA is expected to decide on label changes for antidepressants within a few months.

Statistics:

• 2 or 3 more patients become suicidal for every 100 given antidepressants compared to those given placebos.
• 15 members of the FDA advisory committee voted in support of the black box warning, with 8 members opposing it.
• 11 million prescriptions for antidepressants were written to teenagers and children in 2002, representing almost 8 percent of all antidepressant prescriptions.
• Antidepressant prescriptions for youngsters continued to climb by nearly 8 percent after the FDA mandated in March that manufacturers state on drug prescription sheets that they may be linked to suicide.
• Pfizer spends millions of dollars advertising Zoloft, its huge-selling antidepressant.

Sources:

• "Advisory Panel Votes to Add Warning Labels for Antidepressants" by The New York Times, published on the New York Times website (no date provided)
• The FDA advisory committee meeting transcript, dated February 13-14 (no year provided)