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Opinion: Time To Lift The Black Box Warning On Antidepressants

Paxil, or paroxetine, an antidepressant that raised early alarms about possible suicidal effects in the United Kingdom. (Wikimedia Commons)

Paxil, or paroxetine, an antidepressant that raised early alarms about possible suicidal effects in the United Kingdom. (Wikimedia Commons)

By Drs. Steve Schlozman and Gene Beresin
Guest contributors

In 2004, the Food and Drug Administration made the difficult decision to apply a “black box” warning to virtually all antidepressant medications.

A few months earlier, British health officials had issued a similar warning for paroxetine, or Paxil, a frequently used antidepressant. Both the United States and the United Kingdom were worried about the possibility of antidepressant use in some people causing an increase in agitated, and even suicidal, behavior. The warnings, still in effect, apply particularly to adolescents.

But recent research suggests that perhaps the black box warning should itself have a black box warning. A new Harvard study suggests the warning has actually led to an increase in suicides because it caused a decrease in the treatment of depression through antidepressant prescriptions. Similar studies published back in 2007 showed a fairly dramatic increase in suicide attempts by adolescents, corresponding to a decrease in prescriptions for antidepressants. The Harvard study is a reiteration of these previous findings.

We believe it is time for the black box warning to be lifted. And we suspect that bias and ignorance may play a role in the fact that it has not been.

First, some background information.

A “black box warning” is a written message that by U.S. law must accompany every prescription for which the warning is indicated. Continue reading