Janssen Pharmaceutica Inc., Titusville, N.J., announced in March of 2000 that it was voluntarily withdrawing Propulsid (cisapride) from the U.S. market. Propulsid is a prescription drug treatment for severe nighttime heartburn experienced by patients with gastroesophageal reflux disease (GERD) that does not adequately respond to other therapies.

As of December 31, 1999, use of cisapride has been associated with 341 reports of heart rhythm abnormalities including 80 reports of deaths. Most of these adverse events occurred in patients who were taking other medications or suffering from underlying conditions known to increase risk of cardiac arrhythmia associated with cisapride. (more here)

Propulsid has been associated with a significant number of reports of heart rhythm abnormalities and several deaths. Most adverse events have occurred while patients were taking other medications or suffering from underlying conditions known to increase risk.

Since the drug's approval in 1993, its label has been revised several times to inform health care professionals and patients about the risks. But despite these risk management efforts and additional steps that have been under consideration, the firm decided in consultation with FDA that continued prescription access to the drug poses unacceptable risks. The company will, however, continue to make the drug available to patients with severely debilitating conditions for whom the benefits may outweigh its risks, and who meet specific clinical eligibility criteria for limited access.

Patients currently taking Propulsid are urged to promptly contact their health care providers to discuss alternative treatments. Physicians who are treating patients with severely debilitating conditions are encouraged to contact Janssen at 1-800-JANSSEN.

Propulsid Links

A letter from Janssen Pharmacuetica to Doctors warning of Propulsid dangers

Propulsid Product Liability Litigation (MDL-1355), United States District Court Eastern District of Louisiana

Infant Death Tied to Lax Review of Propulsid (WebMD article)

Popular Heartburn Drug Continues to Cause Deaths (WebMD article)

Heartburn Drug Withdrawn (WebMD article)

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