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FDA Panel Calls for Strongest Warning on ADHD Drugs

In close vote, committee recommends 'black box' label for methylphenidates such as Ritalin
HealthDayThursday, February 9, 2006
THURSDAY, Feb. 9 (HealthDay News) -- A U.S. advisory panel recommended on Thursday the strongest possible label warning for Ritalin and other stimulants used to treat attention-deficit hyperactivity disorder because of potential cardiac risks.
The Food and Drug Administration advisory committee voted 8-7, with one abstention, to add a "black box" warning to the drugs, which include methylphenidates such as Ritalin, Concerta, Methylin and Metadate. Amphetamines, including Adderall, are also commonly used for the disorder. In August 2004, the FDA added a warning to Adderall, telling patients with heart conditions not to use the drug.
The recommendation came after reports of the deaths of 25 people, 19 of them children, among people using both types of medications.
read the complete story on the National Institutes of Health website by clicking here.