New warning for adults taking antidepressants
NEWS IN BRIEF — Posted July 25, 2005
The Food and Drug Administration issued a Public Health Advisory July 1 to boost warnings that adults taking antidepressants face a heightened risk of suicide. The warning was issued after several recent publications suggested there was increased risk, according to the agency.
Adults being treated with antidepressant medication, particularly those being treated for depression, should be watched closely for worsening depression and for increased thoughts of suicide or suicidal behavior, the FDA said.
Close monitoring could be especially important early in treatment or when the dose is either increased or decreased.
Although the advice is similar to that already on the labels of the antidepressants under review, the FDA intends to study the many hundreds of individual clinical trials of the medications involving thousands of adult patients. The study is expected to require a year or more to complete.
It will follow a similar process undertaken by the agency to determine the suicide risk for children who are prescribed antidepressants. That review resulted in black-box warnings about the link between the antidepressants and suicidal behavior in children. The drugs under review include Effexor, Paxil, Prozac, Zoloft and Wellbutrin.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2005/07/25/hlbf0725.htm.