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The Food and Drug Administration advisory committee voted for the strictest possible warning on attention deficit disorder drugs including Novartis AG''s, Ritalin and Shire''s Adderall. The new black box label will warn millions of consumers of the possible risks of sudden death and heart problems associated with ADHD drugs .

This decision was made on February 9, 2006 by an eight-to-one vote. The meeting was convened to discuss further evaluations of the risks associated with ADHD drugs, but this new black box label recommendation may strengthen the FDA''s recent reports of the link between ADHD drugs and possible fatal side effects.

Panel member and Cleveland Clinic heart specialist Steven Nissen made the motion to add the new label. “We can''t just discuss future strategies, we need to discuss what needs to be done now about the risks and inform people about them,” Nissen said

Nissen believes that it is the responsibility of the FDA to warn consumers of the possible risks associated with Ritalin, Adderall and other similar drugs. Nissen said that if during the course of the studies, researchers find no connection between the more than 51 death reports, then the black box label can be removed.

The FDA panel have issued that the following central nervous system stimulants are required to add a black box label, which warns of the potential cardiovascular and death risks:

• Novartis AG''s Ritalin and Focalin
• Shire Pharmaceutical''s Adderall
• Johnson & Johnson''s Concerta
• Tyco and Alliant''s Methylin

About one million ADHD drug prescriptions are filled each month for adults and two million are filled for children . This FDA advisory committee meeting marks the third time in two years the FDA has discussed the serious cardiovascular side effects from ADHD drugs.