The FDA's Drug Safety and Risk Management advisory committee last month voted to recommend adding "black-box" warnings to stimulants used to treat ADHD, alerting doctors and patients of the risks these drugs have on the cardiovascular system.
The FDA is not required to follow the recommendations of its advisory committees, but usually does.
The latest reviews show that psychosis or mania can occur in some juvenile patients at normal doses of any ADHD drug. The reviews included roughly 90 studies of the drugs as well as reports from doctors, parents and others.
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