Antidepressant Safety Concerns Are Increasing

September 24, 2004 1 min read

Could antidepressants be the cause of suicidal behavior in some children?

A statement released by the U.S. Food and Drug Administration last week suggests the answer is yes, signaling a major change in the agency’s position.

An advisory committee for the federal agency, which met Sept. 13 and 14, reviewed data about antidepressants at a two-day public hearing.

The statement, released two days after the committee’s meeting, recommends that any warning related to the increased risk of suicidal thoughts be applied to all antidepressant drugs.

In February, FDA officials asked drug manufacturers to place stronger warnings on the labels of 10 antidepressants to alert people to monitor patients closely for signs of suicidal behavior.

A controversial report released earlier this year in Britain concluded that antidepressants contributed to suicidal behavior in children. Drug manufacturers have disputed those findings.

Susan Bro, a spokeswoman for New York City-based Pfizer Inc., which manufactures the widely used antidepressant Zoloft, said that her company supports the agency’s February recommendation to monitor pediatric patients for suicidal behavior.

“Clearly, we share the FDA’s concerns to this vulnerable population,” Ms. Bro said. “Pfizer supports careful patient monitoring.”

The advisory committee is recommending that the FDA require drug companies to place “black box” labeling with bold type on information sheets that accompany the drugs. The labeling would discuss warnings and specific issues that physicians and patients should consider before beginning treatment.

But Pfizer officials are worried that grouping drugs without considering each company’s clinical data could jeopardize the availability of beneficial treatments.

“One of our major concerns in this dialogue is how overlooked the problem of major depression is, especially when left untreated,” Ms. Bro said.