FDA panel wants 'black box' on ADHD drugs
A federal advisory panel is suggesting that the FDA should require its toughest warning label for ADHD drugs like Ritalin. The recommendation came as a surprise to the FDA, which typically follows the advice of its advisory panels but isn't required to. One possible follow-up would be for the FDA to ask for advice from a separate panel. At issue are reports of heart disease that may be linked to the drugs. The agency has track the deaths of 25 people and 54 cases of serious cardiovascular problems among the many people taking the drugs. A "black box" warning could be removed at a later stage if follow-up studies failed to confirm the link.
- read this AP report for more information
ALSO: The U.K.'s Shire, which makes Adderall XR, immediately followed up with a call for further studies into ADHD therapeutics. Article
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