An FDA advisory panel last week recommended adding the agency's strongest possible safety warning for Ritalin and other popular attention-deficit drugs. Here's what's behind the buzz:
Is the proposal based on new data? No. The panel had been tasked with suggesting studies to explore the cardiovascular effects of these drugs. The idea of adding a "black box" warning came as a surprise.
Do these drugs pose a risk to the heart? Maybe. Ritalin and its cousins Concerta and Adderall are stimulants that can raise heart rate and blood pressure. The FDA knows of 25 cases of people--19 of them children--dying suddenly while on the drugs and dozens of cases of stroke and arrhythmias, but cause and effect are far from certain. Those are small numbers given that 2.5 million kids and 1.5 million adults in the U.S. take the drugs, but some panel members think many cases may go unreported. Cardiologist Steven Nissen, who proposed the warning, is worried about adults on the drugs, 10% of whom are over 50 and may have other risk factors for heart trouble.
Is the warning warranted? Not at this point, says Dr. Thomas Laughren of the FDA. But the agency will review the risk labels on the drugs and probably launch a formal study of cardiovascular dangers. Over-prescription is another big concern. Nissen notes that 10% of 10-year-old boys are being treated for attention-deficit/hyperactivity disorder.
What should patients and their parents do now? Talk to their doctor, especially if the patient has a heart problem or a family history of cardiac trouble.