Thursday, June 30, 2005

Concerta Review Shows Unexpected Psychiatric Reactions in Children

The FDA, after a Concerta review, plans to strengthen warnings about the possible psychiatric side effects of Concerta and similar drug treatments for ADHD. A routine FDA review of Concerta unearthed unexpected psychiatric reactions in children - psychotic behavior, suicidal thoughts, hallucinations and aggression - in addition to heart complications.

Concerta, a once-daily form of methylphenidate (Ritalin), is now the most prescribed drug for ADHD. A subsequent review of other methylphenidate products found similar psychiatric complications. The FDA plans to conduct a review of Adderall and Strattera to see whether similar behavior is reported with these ADHD drug treatments. That review is expected to be complete early in 2006.

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