FDA panel wants ADHD warning

An FDA advisory committee voted 8-7 Thursday to recommend the addition of a black box warning about cardiovascular risks of stimulants to treat ADHD. The Drug Safety and Risk Management Advisory Committee also voted unanimously to provide medication guides to physicians who prescribe and to patients or their parents who receive ADHD drugs.

The committee's recommendations were unexpected because FDA only asked for advice about the design of safety studies, Robert Temple, director of FDA's Office of Medical Policy, told reporters. "The committee plainly wanted to tell us that certain things ought to be in labeling in a more forceful way," he said. Temple and Thomas Laughren, director of FDA's Division of Psychiatry Products, emphasized their concerns that strong warnings could deter patients who could benefit from ADHD drugs from receiving treatment. ...