Cisapride

Patients who rely on cisapride--and the physicians who treat them--will not be left in the lurch by the drug's upcoming removal from the U.S. market.

The Food and Drug Administration has put both the tablet and suspension preparations of cisapride (Propulsid, Janssen Pharmaceuticals, Titusville, N.J.) on a limited-access program, in the wake of Janssen's decision to stop marketing it in the United States effective July 14. Janssen agreed to the marketing halt in response to FDA concerns about the drug's safety.

After July 14, physicians will be able to prescribe cisapride under the FDA's limited-access program. Physicians can expect to receive information on the program from the FDA this month. Enrollment will start on May 1.

Dr. Richard W McCallum said in a telephone interview that he doubts that physicians treating patients with nocturnal heartburn will be willing to go through the hassle of prescribing cisapride once the limited access program is in place. Instead, they will prescribe one of the many other effective treatments for this disorder: proton pump inhibitors, [H.sub.2] blockers, Carafate, antacids, and lifestyle changes.

Cisapride's only FDA-approved use is for the treatment of nocturnal gastroesophageal reflux disease, but its most important use in practice is in the management of gastric motility problems below the esophagus, noted Dr. McCallum, director of the Center for GI Motility Disorders at Kansas University Medical Center, Kansas City.

For impaired gastric motility below the esophagus, Dr. McCallum said that he will do whatever the FDA requires to go on prescribing cisapride because there are almost no alternative therapies for these patients. This patient population includes 12 million diabetics with gas-troparesis as well as patients with gastric motility problems resulting from connective tissue diseases or postsurgical problems.

Most primary care physicians who manage patients with diabetic gastroparesis will probably refer these patients to gastroenterologists rather than deal with the complications of the limited access program, he predicted.

Within 1-2 years, physicians can expect to see the "sons and daughters of cisapride" hit the market. Several agents to speed gastric motility below the esophagus are in various stages of development, Dr. McCallum said.

In the meantime, some physicians will resume use of metoclopramide (Reglan), another established motility stimulant. But, 30% of patients can't tolerate it. Another option is the antibiotic erythromycin, which can be given intravenously in low doses to increase motility below the esophagus. Unfortunately, many patients develop dose tolerance quickly, he said.

The FDAs action was triggered by reports of sudden cardiac death in about 80 patients taking cisapride. Less dramatic steps such as the addition of major labeling warnings and physicians education programs had not reduced cisaprideassociated deaths.

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