FDA Orders Antidepressant Warning Labels

The FDA today issued its strongest warning label for antidepressants prescribed to children and teens, taking the unusual step of shipping the drugs in black boxes to alert doctors that the medications can raise the risk of suicidal thoughts and behavior.

The government also is working with pharmaceutical companies to include a printed guide for patients that describes in greater detail the risk of taking antidepressants and urges that actions be closely monitored.

The labeling changes, made known today in a letter sent to manufacturers, will not prohibit doctors from prescribing antidepressants to children and teenagers, who last year totaled more than 15 million.

Rather, the new warning is intended to encourage users and their caregivers to balance the risk of suicidal behaviors with clinical need.

But some critics believe that the agency’s move could backfire. The American Psychiatric Assn., a trade group of 36,000 physicians who specialize in mental illness, said it had a “deep concern” that such warnings could have “a chilling effect” on doctors prescribing antidepressants for patients.

“This would put seriously ill patients at grave risk,” the group said.

The change came only a month after two Food and Drug Administration advisory panels urged the agency to take the urgent step. The panels recommended that drug companies be required to prominently warn young patients and their caregivers that clinical trials had shown that children taking the drugs were twice as likely to exhibit suicidal thought or behavior as those taking placebos.

They were swayed, in part, by parents who have badgered government regulators for years to warn of the risk of suicide among young people when taking antidepressants.

Under intense pressure for its slow response to antidepressants, the agency said today’s step reflected a desire to further protect young people while treating their depression.

“We continue to believe, however, that these drugs provide significant benefits for pediatric patients when used appropriately,” Dr. Lester Crawford, the acting FDA commissioner, said at a Washington news conference today.

Prozac is the only drug the FDA has approved for treating depression in children and teenagers. But the new warnings will be carried by all brands, including Paxil, Zoloft and Zyban.

Times wire services contributed to this report.