STAT

Opinion: FDA’s continuing use of ‘black box’ for antidepressants ignores the harms of this warning

The FDA's "black box" warnings on antidepressants go too far and harm more people than they help.
Paxil and other antidepressants carry a black box warning, the most serious type of warning in prescription drug labeling.

The Food and Drug Administration’s “black box” warnings and advisories give important safety information about drugs. But they can sometimes go too far and harm more people than they help.

Take the FDA’s highly publicized warnings that taking antidepressants increases the risk of suicidality (defined as serious thoughts about taking one’s own life or planning or attempting suicide) among children, adolescents, and young adults. We have evidence, as do many others, that these warnings have decreased youths’ access to mental health care and increased suicide attempts. So far, the FDA has refused to accept this evidence.

Depression in young people is a disabling and stigmatizing, both in the U.S. and around the world. It is the , which climbed by about among adolescents between 2003 and 2016.

You’re reading a preview, subscribe to read more.

More from STAT

STAT2 min read
STAT+: Pharmalittle: We’re Reading About CVS And Humira Biosimilars, Schumer’s Broken Insulin Promise, And More
New prescriptions for biosimilar versions of Humira, one of the best-selling drugs in the U.S., surged to 36% from just 5% during the first week of April.
STAT2 min read
STAT+: Pharmalittle: We’re Reading About AstraZeneca CEO Pay, Alternatives To WuXi And More
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans.…
STAT1 min readAmerican Government
Opinion: As A Rule, Rape Exceptions For Abortion Don’t Work
Abortion opponents often say they want to support survivors of rape. But abortion bans do the opposite, and no fake "rape exception" is going to change that.

Related Books & Audiobooks