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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.

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