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Committee votes to add black box to ADHD drugs

The FDA Drug Safety and Risk Management Advisory Committee voted 8 to 7 in favor of adding a black box warning to the labeling of all stimulant drugs used to treat ADHD. The group also voted unanimously (15-0) in support of requiring that FDA medication guides be distributed with each stimulant prescription, explaining the potential risks to patients and their families. These recommendations are the result of concerns that the drugs may increase one's risk of sudden death. The FDA said that 25 children and adults have died suddenly from 1999 to 2003 after taking the drugs. Some FDA officials have called the sudden death data unpersuasive, saying that the reports do not prove that the drugs caused the problems. In addition, Shire plc, maker of Adderall XR, released a statement following the FDA meeting calling any change to its existing labeling unwarranted and instead supporting further study to determine whether a relationship between ADHD drugs and cardiovascular events actually exists. IMS Health reports that 31 million prescriptions for the stimulant drugs were dispensed last year alone. FDA's Pediatric Advisory Committee plans to meet March 22 to further discuss the medications.

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