Did FDA Black Box Warnings Actually Lead to An Increase in Suicides?

Jul 1, 2014

Antidepressant use as a treatment for depression and other mental health disorders began to gain popularity in late 80’s and early 90’s. As doctors and psychiatrists slowly shifted their preferred method of treatment from therapy to medication, rates of antidepressant use began to rise. By the early 2000’s up to 10 percent of adults and almost three percent of adolescents were on a regular antidepressant regime.

This positive attitude towards antidepressant use for children changed in 2003 after the FDA began publishing black box warnings on antidepressant medication. The warnings cautioned parents that antidepressant use in adolescents may increase thoughts of suicide. The warnings were magnified by intense media coverage that fixated on and may have exaggerated the dangers of adolescent antidepressant use.

A recent study published in the BMJ and conducted by Harvard Medical School’s Department of Population Medicine and the Harvard Pilgrim Health Care Institute, provides evidence that these warnings may have backfired.  Following the publication and media scrutiny of the 2003 warnings, it was found that antidepressant use in young people dropped by over 20 percent. Correspondingly, the same year saw an increase of 22 percent in suicide attempts by overdose with psychotropic drugs in adolescents and a 34 percent increase among young adults.

“This study shows an association of fewer antidepressants and increased suicide. That doesn’t prove it is the cause, but it is a striking correlation on a population basis,” said Ken Duckworth, M.D., medical director of NAMI.

This study was one of the first to determine how a health outcome can be influenced by public policy and mass media.

Though the FDA warnings were undoubtedly well-intentioned, the surrounding media flurry generated an aversion to antidepressant medications. Many parents chose not to have their children treated with antidepressants out of fear that it would cause suicidal thoughts. What was not relayed to the public was that suicidal thoughts only occurred in about one percent of adolescents taking antidepressants. Young people who were taking antidepressant medication also did not have an increased risk of suicidal attempts or actions.

“When I testified at the FDA hearing on this issue in 2003, I emphasized that the risks of no treatment should be mentioned in the black box warning,” said Duckworth. “People need to be able to weigh all their choices to make informed decisions. “

Before the black box warning was released, the number of attempted suicides was decreasing. Since it has been published the rates of adolescent antidepressant use have remained low and suicide attempts continue to rise. This information suggests that the FDA warnings had a profound and lasting effect on the public’s perception of antidepressant medication.

Though medication may not be the best treatment for everyone experiencing depression, it can save lives. Some adolescents will respond much better to antidepressants than any other form of treatment. As a parent or caretaker of a young person with mental illness, it’s important to weigh the pros and cons of all treatment options.

“It's important to understand the risks of treatment as well as the risks of no treatment,” said Duckworth. “Be sure to look at all options including psychotherapy and psychosocial supports not simply medication.”