FDA Advisors Warn: “Raise Ritalin Warning To Black Box”— The Most Serious Level Available

In a surprise move, an advisory panel for the Food and Drug Administration voted 8 to 7 to suggest that the patient warning label for stimulants such as Ritalin carry the most serious warning the FDA issues: the Black Box warning (so named because the text of the warning is bordered by a heavy black box attention).

          The FDA had asked this panel simply to determine how to research possible heart risks of the class of drugs— not advise on labeling!

          The panel heard testimony from FDA medical officers who noted that 25 sudden deaths- mostly among children- occurred among people taking stimulants and a preliminary analysis of millions of health records suggested that stimulants might increase the risk of stroke and arrhythmias (irregular heartbeat).  One of the stimulants, Ritalin, has been marketed since 1955, but has never been studied over a long enough time to evaluate its long-term effects on the heart. And growth of Ritalin prescriptions in the last several years has been explosive.

          One of the panel members, Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, said, “I have grave concerns about the use of these drugs and grave concerns about the harm they may cause.  I want people’s hands to tremble a little bit before they write that prescription.”

          Arthur A. Levin, director for the Center for Medical Consumers in New York City and also a member of the panel, said that patient assumed that these stimulants were safe but that confidence was misplaced. “For us to sit around and talk about it, and for us to not make a very strong warning about the uncertainty of these drugs and their possible risks would be unethical,” he stated.

          William Pelham, director of the Center for Children and Families and the State University of New York said that if families explored alternative treatments to these drugs that “would be a very good outcome for kids with A.D.H.D. and their families.