Watchdog Asks FDA to Regulate Leaflets

Leaflets that provide brief bits of information about drugs are actually posing risks to patients, according to the watchdog group Public Citizen. At issue are patient information leaflets, small sheets that pharmacists or hospitals give patients with prescription drugs. The leaflets offer a brief explanation of the proper use of the drug and its side effects in a less formal way than the package labeling required by the Food and Drug Administration. Sidney Wolfe of Public Citizen’s Health Research Group said the information leaflets can lull patients into a false sense of security without thoroughly warning them of the risks of taking a prescription drug. He and his group petitioned the FDA to regulate or recall the leaflets. Pharmacies or hospitals pay companies to develop the leaflets as an aid for patients. They usually have nothing to do with the drug companies, though drug makers sometimes review the leaflets for the companies that print them. Thomas McGinnis of the FDA said the patient information leaflets are meant to “reinforce” discussions between patients and their doctors and pharmacists, not provide a substitute for them. The companies that make the leaflets say they are offering a service to patients by providing easy-to-read information about a drug.