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FDA Backs Stronger Warnings for Some Antidepressants

BY Admin  March 22, 2004 at 4:32 PM EDT

The Food and Drug Administration has been investigating a possible connection between the drugs and suicides in children. The warning issued Monday, however, is aimed at adults as well as children.

In a statement, the agency cautioned that “it is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior.”

Despite the continuing uncertainty, the FDA issued an advisory that asks doctors, patients, families and other caregivers to watch for signs of worsening depression or suicidal tendencies at the beginning of treatment with antidepressants or when the dose is changed.

“We think this is good advice whether the drugs increase the risk or not,” said FDA medical policy chief Dr. Robert Temple. “There’s a reason people are put on therapy — their depression is worse or somebody’s worried about it. Maybe that’s what drives it (reports of suicides) or maybe it’s the drugs. In either case, you really need to pay attention in the early days.”

The ten drugs included in the advisory are all among the newer-generation of antidepressants. They are Prozac, Paxil, Zoloft, Effexor, Celexa, Remeron, Lexapro, Luvox, Serzone and Wellbutrin.

Only Prozac is approved for treating pediatric depression.

Investigating the possible link between the drugs and suicide is proving challenging for the FDA.

Among 25 studies of the suspect medications involving 4,000 children and teens, there were no completed suicides. However 109 patients experienced one or more possibly suicide-related behaviors or attempts, the FDA reported. Those studies varied dramatically in what was considered suicidal behavior, making analysis difficult, FDA contended. For example, 19 of those 109 cases involved patients who had cut themselves, but almost all of those patients inflected only superficial wounds on themselves.

Until the FDA concludes its analysis, the agency called on doctors to closely monitor for signs of hostility, anxiety, insomnia and other behaviors that could signal worsening depression and suicidal thoughts. The FDA plans to hold a public meeting to provide an update on its research this summer.

Monday’s FDA decision comes after British health authorities declared last year that — with the exception of Prozac — these newer antidepressants were unsuitable for depressed youth.

Depression occurs in up to 10 percent of youth, and 1,883 young people in the United States ages 10 to 19 killed themselves in 2001. Some 1.8 million teenagers attempted suicide that year, a quarter of them requiring medical attention, according to Columbia University scientists who are working with the FDA.