Cisapride (Propulsid), a prescription drug used in the treatment of severe nighttime heartburn in patients with gastroesophageal reflux disease, will be voluntarily removed from the U.S. market as of July 14, 2000. The effective date should allow enough time for patients and physicians to make alternative treatment decisions. After July 14, the manufacturer will continue to make the drug available to patients who meet specific clinical eligibility criteria for a limited-access protocol.
As of December 31, 1999, the use of cisapride has been associated with 341 reports of heart rhythm abnormalities, including 80 reports of mortality. Most of these adverse events occurred in patients who were taking other medications or had underlying conditions known to increase the risk of cardiac arrhythmia associated with cisapride.
Since cisapride was approved in 1993, the labeling has been revised several times to inform patients and physicians about the possible adverse effects. Despite these risk management efforts, the manufacturer has decided that access to the drug poses unacceptable risks and will remove it from the U.S. market.
Patients who are using cisapride should contact their physicians to discuss alternative treatment options. Physicians who are treating patients with severely debilitating conditions for whom they believe the benefits of cisapride may still outweigh the risks are encouraged to contact Janssen at 800-JANSSEN (800-526-7736). More information on the voluntary removal of cisapride from the U.S. market can be obtained by calling the FDA at 888-INFO-FDA (888-463-6332). This information can also be accessed on the FDA Web site (http:// www.fda.gov).
COPYRIGHT 2000 American Academy of Family Physicians
COPYRIGHT 2000 Gale Group
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