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A Food and Drug Administration panel said Thursday the agency should move forward with plans to rewrite labels for Concerta, Ritalin and other drugs widely used to treat attention deficit hyperactivity disorder to more clearly warn of the possibility of hallucinations and suicidal tendencies in patients taking the drugs.

While such reports of serious psychiatric problems are rare and there is no proof they were caused by the drugs, the FDA said a fuller discussion of the reports should be on drug labels. Current labeling discusses psychiatric problems that could be associated the drugs, but agency officials said they believe the labels don't clearly spell out the frequency and types of specific psychiatric problems. The FDA made its decision to rewrite labels after reviewing 135 adverse event reports from Dec. 4, 2003, to Jan. 4, 2005 , involving Johnson & Johnson's (JNJ) Concerta, a long-acting form of methylphenidate, the generic name for Ritalin, made by Novartis AG . (NVS).

The Concerta review was mandated by law in drugs that are studied for use in children. Almost eight million prescriptions were written for Concerta during the same time period covered by the FDA review.

"The agency is struggling," said Dianne Murphy, director of the FDA's office of pediatric therapeutics. "We have a concern, but we may not be able to articulate it with certainty." Murphy and other FDA officials said they are only rewriting labels and aren't thinking about placing a stricter "black box" warning on ADHD drugs.

The FDA brought the review of Concerta to its pediatric advisory panel for advice on how best to communicate its concerns to the public. The agency didn't focus on another category of ADHD drugs that includes Shire Pharmaceuticals PLC's (SHPGY) Adderall, which was ordered off the market earlier this year in Canada after reports of 20 sudden deaths in patients, including 12 strokes.

The FDA is already reviewing ADHD drugs for links to more serious problems like stroke. The drug labels already warn of increased blood pressure and suggest the drugs can make any underlying psychiatric disorders worse. New labeling changes won't take place until the cardiovascular and psychiatric reviews are complete early next year.

Patrick Ciccone, vice president of medical affairs for the J & J unit that makes Concerta, said the company is reviewing the adverse-event reports with the FDA and would "do what's in the best interest of patients."

Of the 135 adverse event reports involving Concerta, the FDA was mainly concerned with 36 psychiatric events in young people. Of those, six patients have a previous history of psychiatric illnesses. Some of the patients reported hallucinations, suicidal thoughts and suicide attempts.

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