This article is from the WebMD Medical News Archive

June 30, 2005 -- Federal regulators said Thursday that they would likely hold off on issuing new safety warnings for Concerta, a drug used to treat attention deficit hyperactivity disorder. Officials said moving too quickly could unnecessarily alarm the public about potential side effects.

FDA officials are considering altering the drug's label to more clearly alert doctors as well as parents of children with ADHD about potential medication-related side effects including visual hallucinations, psychotic episodes, and aggressive or violent behavior.

The agency has also said it intends to add new warnings that the drug may be related to the emergence of suicidal thoughts in children and adolescents who take it.

Making Parents Aware

But officials said Thursday that they are unlikely to move ahead with the label changes until the agency collects information on similar side effects in the wider class of stimulant drugs used to treat ADHD. The review is likely to be completed in early 2006, officials said.

At the same time, regulators -- who have pledged new openness about drug safety concerns -- say they want parents of millions of children who take the popular medications to be aware of potential side effects.

"We want to try to make it clearer what the situation is with the potential adverse events," says Dianne Murphy, MD, director of the FDA's office of pediatric therapeutics.

About 1 million American children between 6 and 17 take Concerta, sold by McNeil Consumer & Specialty Pharmaceuticals. Millions more take similar stimulant drugs including Ritalin and Adderall. McNeil and Ritalin's manufacturer Novartis are WebMD sponsors.

Strattera, another ADHD drug, is not a stimulant. Strattera's maker, Eli Lilly, is also a WebMD sponsor.

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