• Posted October 8, 2024

Were FDA's 'Black Box' Warnings on Antidepressants a Mistake? Youth Suicides Rose Afterwards

"Black Box” warnings added to antidepressants might have contributed to an increase in suicide attempts and deaths among young people, a new evidence review claims.

The warnings say that antidepressants might be associated with suicidal thoughts and behaviors in children and teens, and were intended to prompt doctors to more closely monitor young people prescribed the drugs, researchers said.

Instead, the warnings caused doctors to think twice before prescribing antidepressants to youth, possibly prompting a decline in mental health among kids and teens, results show.

“The sudden, simultaneous and sweeping effects of these warnings -- the reduction in depression treatment and increase in suicide -- are documented across 14 years of strong research,” said lead researcher Stephen Soumerai, a professor of population medicine at Harvard Medical School’s Pilgrim Health Care Institute.

Since 2003, the U.S. Food and Drug Administration has advised that antidepressants could be linked to suicidal thoughts and behaviors in young people.

The FDA required that a Black Box warning be placed on antidepressants in 2005, notifying doctors of this possible effect in kids younger than 18. In 2007, the FDA expanded the warning to include young adults up to age 24.

To see how the warning might have affected treatment of depression, researchers analyzed the pooled data from 11 studies between 2003 and 2022.

The data show that fewer than 5% of young patients were monitored for suicidal thoughts and behaviors as recommended by the warning. This rate remained the same before and after the FDA required the warning.

On the other hand, seven studies found that antidepressant treatment and use declined between 20% and 50% during that time.

Studies also showed increasing use of antidepressants in the years before the FDA warning, followed by abrupt and sustained decreases in use after the warnings were issued.

“The consistency in observed harms and absence of observed benefits after the Black Box warnings indicate this is not a coincidence,” Soumerai said in a Harvard news release. “We recommend that the FDA consider incorporating the Black Box warnings into the list of routine warnings that pose fewer health risks, or potentially removing the warnings altogether.”

The new study was published Oct. 7 in the journal Health Affairs.

If you or a loved one are experiencing a suicidal crisis or emotional distress call the Suicide and Crisis Lifeline at 988.

More information

The Mayo Clinic has more on antidepressants.

SOURCE: Harvard Pilgrim Health Care Institute, news release, Oct. 7, 2024