FDA bolsters black box on antidepressants to warn of suicidality in young adults

Share this article:
The FDA asked antidepressant makers to update the black box warnings on their products to caution against increased risks of suicidality in young adults starting on the meds. The proposed labeling warns of increased risk of suicidality for users age 18-24 in the first two months of treatment, but says that scientific data do not show increased risk in adults over than 24 and that those 65 and older have a decreased risk of suicidality. The language also emphasizes that depression and other serious psychiatric disorders treated by the drugs are themselves the biggest danger to patients. Manufacturers have 30 days to submit revised product labels and medication guides to FDA for review. In 2005, FDA asked manufacturers to add a black box warning of a suicidality risk in children and adolescents on the drugs and initiated a review of 295 individual antidepressant trials involving 77,000 adult patients with major depressive disorder or other psychiatric disorders. Today’s move stems from the findings of that review.
Share this article:

Email Newsletters

More in News

Lack of marketing partner delays Afrezza launch

Lack of marketing partner delays Afrezza launch

Afrezza was heralded as one of the most innovative diabetes products of the last decade. So, why hasn't MannKind set a firm launch date for the product?

In sunny world of LASIK marketers, a dark underbelly

In sunny world of LASIK marketers, a dark ...

Last week, the former FDA branch chief who originally approved LASIK machines asked FDA to reconsider its denial last month of his petition to ban these devices.

BMS Q2 sales slip, Eliquis, Yervoy soar

BMS Q2 sales slip, Eliquis, Yervoy soar

The company attributed part of the Eliquis boost to the BMS-Pfizer DTC and education efforts.