Drug company investors breathed a sigh of relief Thursday after a group of medical experts said the Food and Drug Administration shouldn't impose a black box warning on treatments for attention deficit hyperactivity disorder.
A black box warning is the FDA's strongest alert, and it usually leads to depressed sales for drugs that carry the warning. However, the panel of outside advisers said labels for ADHD drugs should clearly describe their potential for psychiatric and cardiovascular risks.
The advisory panel, which met for about 11 hours Wednesday, didn't take a formal vote. The consensus opinion contrasted with a vote last month of another FDA committee. That panel voted 8-7, with one abstention, to recommend a black box warning about cardiovascular risks for all but one ADHD drug on the market. The FDA isn't bound by its advisory panels' suggestions. ...
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