Some psych experts want FDA to yank black-box warning on antidepressants

Dr. Wayne Goodman

Should the FDA pull the black-box suicide warning on antidepressants? In light of recent research, some psychiatry experts say yes. But others aren't so sure.

TIME magazine surveyed 17 leaders in the field to get their opinion on the black box warning, which alerts doctors and patients to an increased risk of suicidal thoughts and behaviors in teens and young adults. Eleven of them thought the warnings should be removed. Two others said the media has overplayed the suicide risk, while the remaining four think the warning box should remain. Three of those four advised the FDA to issue the warning 10 years ago, TIME reports.

Part of the reason why the FDA was primed to require that black box warning was the mood of the times, at least one expert figures. In 2004, there was widespread worry about antidepressants and suicides, Dr. Wayne Goodman, chair of psychiatry at Mount Sinai Hospital, told TIME. Goodman led the FDA committees that weighed the data before recommending the warning, which initially applied only to children and adolescents.

"I recognized there could be a chilling effect on prescribing, but I thought it was important to get the message [about possible side effects] out. At least that's certainly what I felt at the time," Goodman said (as quoted by TIME).

The FDA's decision did lead to a decrease in prescriptions, according to recent studies. New data also point to another possible side effect. Harvard researchers recently found that attempted suicides by adolescents increased 21.7% two years after the FDA's warning. For the British Medical Journal study, scientists analyzed claims from 11 insurers and reviewed reports of drug poisonings to determine suicide attempts. Their conclusions: As antidepressant use fell by 31%, attempted suicides among people between 18 and 29 jumped 33.7%.

"Warnings, especially widely publicized warnings, may have unintended consequences," the study's lead author, Christine Lu, an instructor at Harvard Pilgrim Health Care Institute, told Bloomberg at the time the study was published.

But the FDA's plan was never to discourage appropriate use of the products, Thomas Laughren, former director of the FDA's Division of Psychiatry Products, told TIME. The agency chose to issue the warning to assuage public fear, facilitate communication between patients and doctors about associated risks, and make sure physicians monitored patients when they started the new meds.

The agency does not plan to review the warning anytime soon, but many experts are urging the agency to change its tune. "We don't want wild and crazy prescribing, but we don't want good clinicians to be afraid to use useful drugs," said Dr. Mark Riddel, Professor of Psychiatry and Pediatrics at Johns Hopkins (as quoted by TIME). "Though I am generally a cautious person and most of my research is on side effects, I think the FDA needs to back off a little."

Another black box repeal effort is underway. The FDA convened an advisory panel last month to consider revising or pulling the boxed warning on Pfizer's smoking cessation drug Chantix. Agency reviewers recommended against the change, and the FDA's expert advisors voted against it as well. The FDA itself hasn't yet announced its decision.

- read the TIME story
- get more from Bloomberg

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