Food and Drug Administration to Strengthen Warnings for Antidepressant Drugs

Bruce Roberts

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The FDA (Food and Drug Administration) approved the strongest possible warnings for antidepressants to warn patients and physicians that the drug could increase the risk of suicidal thinking and behavior in adults 18 to 24 years of age.

The action comes after a Food and Drug Administration committee recommended the warning after finding small increases in suicidal thoughts, and behaviors by young adults taking commonly used antidepressants. According to the study approximately 5 of every 1,000 patients ages 18 to 24 were at increased risk. There are some 16,000,000 people in the United States who take antidepressants and about 8 percent are people under age 25.

"The risk is small but the risk is real, and it is something that needs to be paid attention to," Dr. Thomas Laughren, director of the FDA's division of psychiatry products, said during a news conference.

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