UPDATE 2-US FDA tells ADHD drugmakers to warn of risks

(Recasts first paragraph, adds FDA and company comments, byline)

By Susan Heavey

WASHINGTON, Feb 21 (Reuters) - Companies that make drugs to treat attention deficit hyperactivity disorder must take extra steps to alert patients to possible cardiovascular and psychiatric risks, U.S. health officials said on Wednesday.

The Food and Drug Administration (FDA) said it told the drugmakers to develop patient-friendly guides that explain the risks and to hand them out with the medications, which already carry label warnings about the risks.

"Despite this new warning language ... we continue to view ADHD as an important ailment that benefits from treatment from this class of medications," said Dr. Tom Laughren, head of the FDA's division of psychiatry products. "We consider these drugs quite safe."

Novartis AG (NVS.N: Quote, Profile, Research, Stock Buzz) (NOVN.VX: Quote, Profile, Research, Stock Buzz), Eli Lilly and Co.(LLY.N: Quote, Profile, Research, Stock Buzz), Johnson & Johnson (JNJ.N: Quote, Profile, Research, Stock Buzz), and Shire Plc (SHP.L: Quote, Profile, Research, Stock Buzz) all make ADHD drugs. Shire also makes an ADHD patch.

Novartis, Shire and several privately held manufacturers said they would work with the FDA to produce the patient information. Representatives of other drugmakers did not have immediate comment.

ADHD can make it difficult for patients to pay attention and can cause hyperactivity and impulsiveness. The FDA said people with ADHD may have low self-esteem, difficulty in school, and trouble relating to family and peers.

The risk of heart and psychiatric trouble in patients taking ADHD medications is not new.