FDA Says: We Won't Remove Warning, We'll Extend It
Last month, I wrote about a report in the Journal of the American Medical Association indicating that, Black Box warning notwithstanding, antidepressants don't significantly raise the risk of suicide for adolescents. The researchers suggested the Food and Drug Administration tone down its warnings on the subject, lest it turn young patients away who really could benefit from the medications.
Not only is the FDA not heeding that request, it's extending the Black Box warning -- the highest possible caution, surrounded by a black border on medication packaging -- from children and adolescents only to everybody under the age of 25.
The FDA's proposed warning will also clarify that people age 25 or older bear no increased suicide risk from taking antidepressants, and that in fact those age 65 and up have a decreased risk with the drugs. But if you're caring for a young person age 24 or below, the agency suggests "appropriate monitoring and close observation," as well as the use of Medication Guides.
Does your child take antidepressants? Do these FDA warnings concern you? Share your experience in the comments.


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