Antidepressant Warning Labels May Not Keep Youths Safe From Suicide: Study

“Black box” warning labels on antidepressants regarding suicidal thoughts and behavior may cause more harm than benefit, researchers warn.

New research suggests that efforts made by federal regulators in recent years to expand antidepressant warnings about the risk of suicidal thoughts and behaviors among children and young adults have been ineffective, and may actually be harmful.

Antidepressants are widely prescribed for depression and have consistently demonstrated an ability to improve mental health outcomes. However, since 2003, the U.S. Food and Drug Administration (FDA) has warned that antidepressants may have the opposite effect for some users and could lead to unintended negative consequences, potentially increasing the risk of suicide among children and young adults.

As a result, the FDA started requiring “black box” warning labels on antidepressants for minors in 2005, and for young adults in 2007, as part of an effort to highlight the serious risks associated with the medications. The information has been placed in a prominent black box at the top of the warning labels, which is the strongest type of warning regulators can require drug makers place on prescription medications.

However, a report published in the journal Health Affairs earlier this month suggests that antidepressant suicide warnings may not only be ineffective, but they may also be leading to less physician intervention for young people’s depression symptoms, which could increase the risk of much more serious and life-threatening depressive episodes.

In the new study, a team of researchers led by Dr. Stephen B. Soumarai of Harvard University reviewed all previously available studies on antidepressant warning labels, to evaluate their impact on youth mental health.

Of the 11 studies examined, none reported improvements in mental health care or declines in suicide attempts or deaths after the warnings were implemented.

In fact, the researchers found that since black box warning labels were added to antidepressants, there have been fewer visits to doctors and therapists for depression, fewer depression diagnoses, less antidepressant use, and an increase in suicide attempts and deaths.

According to the National Institute of Mental Health (NIMH), depression is the primary factor in suicide, and suicide is the second-leading cause of death among 10 to 14-year-olds, as well as the third-leading cause of death among 15 to 24-year-olds.

For these reasons, the study’s authors urge the FDA to reevaluate the use of black box warning labels on antidepressants and to allow independent scientists to review the labels’ positive and negative effects.

“Contrary to the FDA’s intent to increase physician monitoring of suicidal thoughts and behaviors of treated patients, a large longitudinal study suggests that this did not occur,” Soumarai said. “Moreover, a study of eleven million youth in the four largest state Medicaid plans documented that total depression visits declined by almost half in the three years after the black-box warning, which suggests a likely reduction in monitoring of suicidal thoughts and behaviors in youth with depression.”