Antidepressants to carry a suicide warning for young adults
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 follows a similar labeling change approved in 2004 for children and adolescents.
The action comes about 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 age 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, who oversees psychiatric drugs for the FDA.
The action requires drug companies to submit proposed labeling and updated medication guides within 30 days. A total of 36 drugs would display the warning.
About 19 million people in the U.S. suffer from depression, and 16 million are treated with antidepressants. People younger than 25 account for about 8% of antidepressant prescriptions.
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 worry that a warning might discourage young adults from taking the drugs, which many consider among the most effective treatments for depression.
In 2004, suicides increased 8% among children 10 to 14 as antidepressant prescriptions fell in advance of the FDA warning about suicidal thoughts and behavior in children and adolescents, government statistics show. The same year, suicides among youths 15 to 19 rose 12%.
Dr. Carolyn Robinowitz, president-elect of the American Psychiatric Assn., said it was unprecedented for the FDA to include positive information in a warning. She said it would provide a more balanced message.
“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.”
The labels will also state that antidepressants reduced the risk of suicidal thoughts and behaviors in adults 65 and older, the FDA said.
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