March 23, 2006
Reports of Disturbing Hallucinations Deepen ADHD Drug DebateTopics: Medicine
Advisers to the Food and Drug Administration are warning that drugs such as Adderall XR, Concerta, Provigil Sparlon), the ADHD skin patch Daytrana, Ritalin, Strattera, Focalin XR, and others, may cause rare but serious cases of horrific hallucinations, aggression and suicides by children.
Drug-safety experts Wednesday rejected slapping a stern "black box" warning about psychiatric side effects on attention deficit/hyperactivity disorder drugs.The FDA review follows scientific and consumer complaints that have slowed ADHD drug sales in the last year. Read more...
Still, the advisers to the Food and Drug Administration called on doctors and parents to be far more vigilant about the psychiatric side effects, citing rare but serious cases of horrific hallucinations, aggression and suicides by children.
The recommendation by the FDA's Pediatric Advisory Committee came nearly two months after another FDA advisory committee narrowly approved the idea of an black box on ADHD drug cardiovascular risks.
The split decision on "black boxes" -- a bold-faced label that often leads to fewer prescriptions and sales -- could provide some breathing room to makers of ADHD drugs and may deflect harsher FDA action.
Posted by Richard at March 23, 2006 10:50 PM
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