PROPULSID: Marketing Halted as Maker Cites Health Risks
Titusville, N.J.-based Janssen Pharmaceutica said yesterday it will stop marketing Propulsid by July 14 because the popular heartburn drug has been linked with 80 deaths and hundreds of heart rhythm abnormalities. Janssen, a subsidiary of Johnson & Johnson, made the decision with the FDA, which approved Propulsid in 1993 but has since issued several strong warnings about side effects associated with the drug. The warnings resulted in label changes that cautioned patients with certain conditions against taking the drug. Although Janssen said that Propulsid remains safe and effective for the majority of patients, "some inappropriate use" of the drug has continued despite the additional warnings, officials said. Janssen plans to make the drug available on a limited basis for patients who have not found other therapies effective and meet criteria being established in cooperation with the FDA. These patients can enroll in a special program beginning May 1 (Recer, AP/Nando Times, 3/23).
Are Physicians to Blame?
The decisions this week to stop marketing Propulsid and the diabetes drug Rezulin, after repeated warnings about potential side effects, has prompted questions as to whether physicians are reading drug safety warnings developed by manufacturers and the FDA, the Wall Street Journal reports. In both cases, the Journal reports, FDA data suggests that physicians "may not have paid enough attention" to label inserts that warn about the drugs' risk of serious side effects, a factor that the agency must consider when weighing the risks and benefits of a drug. Physicians worry that the current means of alerting them to warnings and other drug information -- generic "Dear Doctor" letters that are often slow to arrive -- is not effective. The FDA says that a decade-old initiative to make current labels easier to understand is now back on track after derailing in the mid-1990s. But another barrier against the efficacy of drug alerts -- a lack of time on the part of physicians to digest all of the recommendations they receive -- promises to be more difficult to address. "They don't have the time to keep up with the changing recommendations. They're not doing it purposely. They are just overwhelmed," Louis Chaykin, a diabetes specialist, said (Adams, 3/24).