Attention Drugs Need Strictest Warning, Panel Says

[Celebration]

http://quote.bloomberg.com/apps/news?pid=10000006&sid=adVLHb863wOw&refer=home

Feb. 9 (Bloomberg) -- Drugs for attention-deficit disorder including Novartis AG's Ritalin should carry the strictest possible warning of potential links to sudden death and heart risks, a U.S. advisory committee voted.

The cautions should be highlighted with a black box on prescribing information, the Food and Drug Administration advisers decided today by an 8-7 vote, with 1 abstention. The FDA, which had sought advice on designing a study of the risks, hadn't asked for a warning recommendation. Cleveland Clinic heart specialist Steven Nissen made the motion during discussion.

``We can't just discuss future strategies, we need to discuss what needs to be done now about the risks and informing people about them,'' Nissen, a panel member, said during the meeting in Gaithersburg, Maryland. ``I think a black box is in order that could be removed if information is obtained that does not implicate the drugs,''

The meeting marks the third time in two years the FDA has addressed the heart-related side effects from attention-deficit drugs. Prescriptions for adults jumped 90 percent from March 2002 to about 1 million filled each month as of June 2005, FDA researcher Andrew Mosholder told the panel. About 2 million prescriptions are filled each month for children.