The Food and Drug Administration on Wednesday approved the strongest possible warning for antidepressants to alert doctors and patients that the drugs could increase the risk of suicidal thinking and behavior in adults 18 to 24.
The so-called black box warning extends a similar labeling change approved in 2004 for children and adolescents.
The action comes nearly five months after an FDA advisory committee recommended the warnings after finding a small increase in suicidal thoughts and behavior among young adults taking 11 commonly used antidepressants. The agency said five of every 1,000 patients ages 18 to 24 were at increased risk.
“The risk is small but the risk is real, and it is something that needs to be paid attention to,” said Dr. Thomas Laughren, director of the FDA’s division of psychiatry products.
The FDA’s action requires drug companies to submit proposed labeling and updated medication guides within 30 days. A total of 36 drugs would display the new warning.
About 19 million people in the U.S. have depression and 16 million are treated with antidepressants. People under 25 account for about 8 percent of antidepressant prescriptions.
In an unusual move, Laughren said the new labels would carry both a warning and positive information on the benefits of antidepressants. The labels would emphasize weighing the risks associated with the drugs against the danger of failing to treat depression and other psychiatric disorders that contribute to suicide.
Some psychiatrists and advocacy groups had been concerned that a black box might discourage young adults who need help from taking the drugs, which many consider among the most effective treatments for depression.
Dr. Carolyn Robinowitz, president-elect of the American Psychiatric Association, said it was unprecedented for the FDA to include positive information in its black box warning.
“We continue to be concerned about ‘black box panic’ on the part of the public,” she said. “But we are very relieved and happy that the labeling made the point about the need for treatment.”
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