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Saturday, March 18, 2006

 

FDA may seek psychosis alerts for ADHD drugs

Drugs children take for attention deficit hyperactivity disorder should carry stronger warnings about the risk of side effects like hallucinations and paranoia, the U.S. Food and Drug Administration said.

Since 2000, the agency has received more than 500 reports of psychosis in children 10 and younger who took ADHD drugs, including Shire Plc's Adderall, Eli Lilly and Co.'s Strattera and Novartis AG's Ritalin and Focalin, a staff review found.
"Signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors," according to an agency review dated March 3. The documents were posted on the FDA Web site in advance of a panel meeting next week.
Full Article by Shannon Pettypiece

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