FDA warns about ADHD drug safety

FDA will require label warnings to describe psychiatric adverse effects and is investigating cardiovascular risks associated with Concerta methylphenidate from Johnson & Johnson (JNJ), and other methylphenidate drug products marketed for ADHD. Psychiatric risks include visual hallucinations, suicidal ideation, psychotic behavior and aggression or violent behavior, according to a document posted in advance of Thursday's meeting of the Pediatric Advisory Committee.

FDA also will present postmarketing reports of adverse cardiovascular events. FDA said, "it is not yet possible to determine whether these events, especially the more serious ones, are causally associated with" ADHD drugs. It noted that a warning about sudden cardiovascular deaths was added in 2004 to the label of Adderall XR from Shire (LSE:SHP; SHPGY). Other ADHD drugs must be examined to determine if they are associated with psychiatric or cardiovascular adverse events, FDA said. ...