The FDA has identified a set of possible safety concerns with Johnson & Johnson's attention-deficit disorder drug Concerta, the agency said in a statement posted on its Web site yesterday.
A panel of FDA advisors is scheduled to discuss post-marketing reports of hallucinations, psychotic behavior, suicidal thoughts and heart complications such as high blood pressure at a meeting in Rockville, Md. tomorrow.
Concerta is a once-daily form of Novartis' Ritalin and the most prescribed drug for attention deficit hyperactivity disorder (ADHD), according to a Johnson & Johnson Web site.
Last year, the FDA gave doctors warnings about sudden cardiovascular death linked to another ADHD drug, Shire's Adderall. Canadian health officials in February ordered Adderall to be withdrawn from the market after it was linked to at least 20 deaths.
A Johnson & Johnson spokeswoman said in published reports that the company would not discuss the FDA's statement ahead of Thursday's meeting.