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FDA May Expand Warnings on Antidepressants

Posted on: Thursday, 14 December 2006, 06:03 CST

By Marilyn Elias

Strong safety labels warning that antidepressants can increase suicidal behavior in children should be expanded to include adults up to age 25, a scientific advisory panel told the Food and Drug Administration on Wednesday.

The advisers endorsed an FDA proposal to update the "black box" labels, ordered for pediatric patients in 2004. The antidepressants raise the risk of thinking about or attempting suicide in young adults, but start to curb suicidal behavior at about age 30, and they're particularly helpful for those over 65, says Thomas Laughren of the FDA.

The new data on adults come from 372 drug-company studies, involving nearly 100,000 patients.

The advisory panel weighed in after a public hearing with emotional speeches -- both for and against expanding the labels.

In the past two years, the FDA's 2004 "black box," its strongest warning, has prompted about a 20% drop in antidepressant prescriptions for children, some doctors and patient advocates said. After a decade of falling U.S. teen suicide rates, the rate rose between 2003, when the first FDA safety warnings came out, and 2004.

Doctors may be shying away from prescribing antidepressants for children who need the pills because they fear the black box, said psychologist Kelly Posner of Columbia University. "What we're seeing are the devastating consequences of not giving kids the treatment they need," Posner said.

Others feared adult suicides could increase with expanded black-box warnings. "Every drug, even aspirin, has risks," said psychiatrist Paula Clayton of the American Foundation for Suicide Prevention. "We don't want to see people go without treatment."

The FDA's scientific panel asked the agency to include the risks of untreated depression in the black boxes, as well.

Others thought the FDA should be warning everyone about links between antidepressants and suicidal behavior. Many who spoke at the hearing wept as they recounted suicides by family members who they said hadn't been suicidal before taking antidepressants.

Kim Witzak of Minneapolis told the panel her 37-year-old husband, Woody, hanged himself in 2003 after a few weeks on an antidepressant prescribed for insomnia. She said they weren't warned that the drug could spur extreme agitation.

"Woody loved life and all that this world had to offer," she said. (c) Copyright 2005 USA TODAY, a division of Gannett Co. Inc.

Source: USA TODAY

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