August 22, 2006
New warning information for ADHD drugs
Two attention deficit hyperactivity disorder (ADHD) drugs must include new information about heart risks and psychotic behavior, the FDA said yesterday.
GlaxoSmithKline’s Dexedrine and Novartis’ Ritalin will include a warning about the possible risk of sudden death and serious heart problems, Reuters reported.
At press time it was unclear whether ADHD drugs from Johnson & Johnson's (Concerta) and Eli Lilly (Strattera) were also ordered to carry the warnings.
The FDA's decision comes months after two separate panels of outside experts offered conflicting opinions on whether the risks warranted black box warnings.