February 16, 2006
FDA panel recommends ‘black-box’ labeling for ADHD drugs
An FDA advisory committee voted to recommend that prescription drugs prescribed for attention deficit hyperactivity disorder (ADHD) carry “black-box” labeling, the agency’s most serious product advisory, warning against cardiovascular risks.
The committee voted 8-7 in favor, with one abstention, to recommend the warning be added to Novartis’ Ritalin, Shire’s Adderall, Eli Lilly’s Strattera and other ADHD drugs.
Doctors prescribe the drugs to an estimated 2 million children and 1 million adults a month.
The FDA will conduct a meeting next month in which it is expected to release additional information about its review of cardiovascular risks associated with ADHD drugs.
Earlier this month, the FDA released details of a study that found 25 people died suddenly and 54 others suffered serious unexplained heart problems while taking (ADHD) drugs from 1999 to 2003.
In 2004, approximately 29 million prescriptions were written for Ritalin, Shire's Adderall and similar drugs. Reports of 20 sudden deaths, 12 among children, prompted Canadian
health officials to halt sales of Adderall XR last February. After studying the issue, Canadian authorities allowed the drug back on the market in August.