FDA to label ADHD drugs for side effects

WASHINGTON, Jun 29, 2005 (United Press International via COMTEX) -- The Food and Drug Administration has announced plans to print possible psychiatric side effects on the labels of drugs including Concerta and Ritalin.

The FDA said it would also investigate other drugs used to treat attention deficit hyperactivity disorder, or ADHD, for similar problems, The Wall Street Journal reported Wednesday.

The organization said on its Web site that it has received reports of patients experiencing hallucinations, suicidal thoughts, psychotic behavior, aggression and violent actions while using forms of methylphenidate -- the generic name for Novartis AG's Ritalin. Concerta, made by Johnson & Johnson, is a long-acting form of methylphenidate.

The FDA said it "intends to make labeling changes describing these events," and has asked its pediatric advisory committee to comment on the reports. However, The Wall Street Journal said the announcement seems to imply that it does not see the label change as an urgent safety issue.