FDA committee votes for warning labels on stimulant drugs

An advisory committee of the Food and Drug Administration voted by 8-7 last week to require drug companies to display a “black box” warning label on several stimulant drugs used to treat attention-deficit/hyperactivity disorder.

The drugs are methylphenidate hydrochloride (sold as Ritalin and Concerta) and the amphetamine formulation sold in the United States as Adderall.

The committee, whose recommendation was unexpected, said the warning was necessary because of the drugs' association with rises in blood pressure and heart rate, which have the potential to increase the risk of heart attack, stroke, or sudden death.

“I must say that I have grave concerns about the use of these drugs and grave concerns about the harm they may cause,” said Steven Nissen, a cardiologist from the Cleveland Clinic and a committee member (New York Times, 10 Feb, A19).

But Thomas Laughren, director of the Division of Psychiatry Products at the FDA, said, “We don't think anything different needs to be done right now.” Top FDA officials said that warning patients about theoretical risks might scare many away from the treatment they need (New York Times 10 Feb, A19).

Stimulants are the most widely prescribed drugs for the disorder, and more than 30 million prescriptions for them are written in the US each year.

The FDA said it had identified 17 cases of sudden death in people who were taking an amphetamine between 1999 and 2003, 12 of them (0.36 per million prescriptions) in children. There were also 35 reports of cardiovascular or stroke problems in people taking amphetamines (0.53 adverse events per million prescriptions).

Although methylphenidate has been in use since 1955, and dozens of studies have shown it to be safe and effective, no long term studies have been done to evaluate its effects on the heart. In 1998 a panel of experts from the National Institutes of Health called for research into the long term effects of treatment with methylphenidate (BMJ 1998;317: 1545).