FDA Concerns Over ADHD Drug Concerta

In the US, the Food and Drug Administration’s Pediatric Advisory Committee is considering strengthening the side effects warnings on Concerta. The drug was introduced in 2003 and the committee is doing a routine review of the drug’s safety. In 2004 thirteen deaths and 243 serious events were linked to Concerta including "aggression, agitation, abnormal behavior, anxiety, depression, visual hallucination, and suicidal ideation".
Pediatric Advisory Committee’s Memorandum briefing papers.

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