Committee advises caution on ADHD drug warnings

Post-market reports of adverse effects associated with Concerta methylphenidate from Johnson & Johnson for pediatric attention deficit hyperactivity disorder (ADHD) are consistent with the safety profile identified in JNJ's NDA submission and with those of other methylphenidates, an FDA advisory committee said Thursday.

The clear consensus of the Pediatric Advisory Committee was that "there is no terrible signal" from the post-market data, but that labels on the entire class could more clearly describe the current state of knowledge about psychiatric adverse effects in pediatric ADHD patients, said Dianne Murphy, director of FDA's Office of Pediatric Therapeutics. The committee stressed that FDA should clearly inform the public that it is not possible to determine which, if any, of the adverse effects reported to be associated with methylphenidates are caused by the drugs. ...