Upcoming for ADHD meds: Black box warning?

March 1, 2006

When the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) held its scheduled meeting last month, the agency was looking for advice on researching a possible connection between stimulant drugs used to treat attention deficit hyperactivity disorder (ADHD) and cardiovascular risk. What they got, to their surprise, was, first, an eight to seven vote recommending that sympathomimetic drugs such as methylphenidate and amphetamine-dextroamphetamine combinations carry a black box warning about cardiac risk and, second, a 15 to zero recommendation for including a medication guide that warns patients of those risks.

When the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) held its scheduled meeting last month, the agency was looking for advice on researching a possible connection between stimulant drugs used to treat attention deficit hyperactivity disorder (ADHD) and cardiovascular risk. What they got, to their surprise, was, first, an eight to seven vote recommending that sympathomimetic drugs such as methylphenidate and amphetamine-dextroamphetamine combinations carry a black box warning about cardiac risk and, second, a 15 to zero recommendation for including a medication guide that warns patients of those risks.

The votes came after FDA medical officers described reports of 25 sudden deaths among patients taking a stimulant medication and presented a preliminary analysis of health records suggesting that such stimulants might increase the risk of stroke and serious arrhythmia in adults and children. Advisory committee member Steven Nissen, MD, a cardiologist at the Cleveland Clinic, told The New York Times that he had "grave concerns about the use of these drugs...and the harm they may cause."

At a press conference after the meeting, Director of the FDA Office of Medical Policy, Robert Temple, expressed reservations about a black box warning in the absence of evidence of established causality, but said the FDA would consider the recommendations of committee members. The FDA's Pediatric Advisory Committee will address the matter at a meeting later this month.