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Following FDA Black Box Warning for Antidepressants, Study Finds Increase in Suicide Attempts

Jun 24, 2014

When the U.S. Food and Drug Administration (FDA) warned about the increased risk of suicidal thoughts in young people taking antidepressants

, the agency hoped its efforts would lower the number of suicide attempts over the years. A study published on Wednesday in the British Medical Journal (BMJ), however, shows the opposite. Researchers found a “small but meaningful” increase in suicide attempts among people between the ages of 10 and 29. Prior to this increase, the use of antidepressants lowered significantly.

The authors of the study attributed the rise of suicide attempts to news coverage that may have exaggerated the risks of antidepressants. This may have caused doctors and patients avoid treatment that may have prevented suicide attempts, The Boston Globe reports.

Christine Y. Lu, a researcher at Harvard Medical School’s Department of Population Medicine and the Harvard Pilgrim Health Care Institute and lead author of the study, stated that “Doctors should consider not just the risk of the drug, but the risk of undertreatment,” according to The Boston Globe.

In 2004, the FDA put a “black box” warning, the agency’s most serious advisory, on all antidepressants describing an increased risk of suicidal thoughts and behavior in children and adolescents. In 2007, the warning was modified, advising doctors to consider the risks of not prescribing them. The new warning recommended doctors to monitor the patients who do receive antidepressants. The agency issued the warning based on studies in 2003 showing that 1 percent of adolescents and young adults experienced an increase in suicidal thinking after taking antidepressants.

The warning was also prompted by concerns about drug companies’ influence on research and prescribing habits. “There was a lot of concern that drug companies had manipulated data and underplayed adverse effects,” said Dr. Gregory K. Fritz, a psychiatry professor at Brown University and president-elect of the American Academy of Child and Adolescent Psychiatry.

Researchers studied the impact of the black box warning by analyzing the rate of nonfatal drug overdoses in the years following. Overdoses are considered the most reliable measure of trends, even though they only account for 40 percent of suicide attempts. Over the course of six years, there was a steady rise in suicide attempts among young people while the use of antidepressants dropped 20 percent. For instance, in the second year after the FDA issued the black box warning, overdoses increased 21.7 percent among adolescents and 33.7 percent among young adults, equating to 2 to 4 more overdoses per 100,000 people.

The findings show that there is an association between the FDA and rise in suicide attempts, but does not prove a causal relationship.

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