Op-Ed: “Black Box” Warning

A decade ago the federal government warned that antidepressants might raise the risk of suicide in youth and young adults. A substantial drop in the use of antidepressants followed, and instead of declining as hoped, suicide attempts have increased among people ages 10 to 29, according to a new epidemiological study from Harvard Medical School’s Department of Population Medicine and the Harvard Pilgrim Health Care Institute.

Despite urging from the American Foundation for Suicide Prevention (AFSP) and other mental health organizations, to include both the risks and benefits of antidepressants in their considerations, the US Food and Drug Administration (FDA) issued a ‘black box’ warning, its strongest possible warning, affixed to the packaging of antidepressants in 2004 in an effort to alert doctors and patients about the increased risk of suicidal thoughts.

Unintentionally, the FDA warnings and media coverage at the time actually created a climate of fear about antidepressants, and exaggerated risk of taking antidepressants among people suffering with depression, their health care professionals and the general public.  Due to this confusion in the marketplace, treatment that may have otherwise prevented suicide attempts was foregone by both doctors and patients because of the warning.

What’s true is that depression can be fatal, and treating depression with antidepressants can actually improve health and save lives.  Unfortunately, when the FDA was considering the decision about whether to issue the black box warnings, the studies used in making the decision only examined the adverse events associated with a medicine, but failed to take into account the positive impact of treatment. Many studies, dating back to Simeon (1990), offer a clear analysis and demonstrate that treatment with antidepressants actually addresses depression and reduces the risk of suicide.

The new study conducted by researchers at Harvard replicates previous findings of Gibbons et al. (2007) and provides another powerful look at what happened following the FDA black box warnings.  Investigators analyzed medical data from 7.5 million people in 11 large health systems that span 12 states.

The authors found that in the second year after the FDA black box warnings were issued, prescription rates of antidepressantsdecreasedfrom baseline rates by 31 percent in adolescents between the ages of 10-17 and by 24.3 percent in young adults ages 18-29.  Prescription rates decreased by 14.5 percent in adults aged 30-64 even though the warning did not refer to them.

Other studies did not find a compensatory increase in the use of other treatments for depression such as psychotherapy, ECT or other medications and data suggest that doctors became less likely to diagnose and treat their patients for depression.

Additionally, the authors found that the rate of suicide attemptssignificantly increased in the two youth age groups: by 22 percent in adolescents, and by 34 percent in young adults. Suicide attempts using other methods and attempts that did not result in a visit to the health care systems were not included, so the actual rates were most likely higher. There was no significant change in the rate of suicide in the study.

A more accurate interpretation of the studies presented to the FDA in 2003 would have led to a recommendation for close follow up and education for patients and family members when starting a new medication. The goal of such a discussion is careful monitoring for any emergence or worsening of suicidal thinking and other possibly related symptoms such as agitation, anxiety or insomnia.  This approach fosters communication and should always be the standard of care when any new medication is started.

This is a cautionary tale of an unintended consequence that occurred when controversial interpretation of science led to an FDA warning, followed by media reports that grossly sensationalized the warning, ultimately impacting physician behavior and the public’s attitude toward the treatment of one of the most disabling medical conditions worldwide, depression.  As a society, we cannot afford to base our approach to this common mental health issue, and one of the most significant risk factors for suicide, on fear, ignorance, or the perpetuation of stigma that interferes with help seeking behavior.


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