Heartburn Drug Removed From Market
WASHINGTON (AP) _ The popular heartburn drug Propulsid, which has been associated with 80 deaths, will no longer be marketed after July, except in special circumstances, its maker and federal regulators said.
Known chemically as cisapride, the drug has been prescribed for patients who suffer severe heartburn, or gastroesophageal reflux disease, and have not responded to other drugs.
Manufacturer Janssen Pharmaceutica of Titusville, N.J., said Thursday it no longer would market the drug as of July 14. The company, a subsidiary of Johnson & Johnson, acted in consultation with the Food and Drug Administration.
Janssen said it will make Propulsid available on a limited basis for certain patients who can enroll in a special program beginning May 1. Other therapies must not be effective for these patients, who must meet criteria being established in collaboration with the FDA.
The drug will continue to be distributed until July 14 and will remain in pharmacies until mid-August, Janssen said in an announcement posted on its Web site.
Patients who are now taking Propulsid are advised to speak with their doctor.
Propulsid, one of J&J’s top selling drugs, was approved by the FDA in 1993. But there has been a series of increasingly strong actions to warn against serious side effects from the drug.
As of Dec. 31, 80 deaths and 341 heart rhythm abnormalities have been associated with Propulsid, FDA officials said Thursday.
Janssen maintained in its announcement, ``Propulsid remains safe and effective for the vast majority of patients when used according to the approved prescribing information.″
In 1998, the FDA announced that there had been some deaths among patients taking the drug and issued a warning that Propulsid was linked to cardiac problems in some patients. The drug’s label was revised then to reflect this concern.
In January, the FDA issued an even more severe warning. Patients were urged to be tested to make sure the drug had not affected their hearts. New labels also warned that Propulsid should not be used by patients with disorders of the heart, kidney or lung, or by patients who were taking some medications to treat heart problems, allergies, depression or AIDS.
Janssen said that despite the warnings, ``some inappropriate use has continued″ in the United States. The best solution, the company said, was limiting access to the drug ``while ensuring that appropriate patients who have exhausted other treatment options can still benefit from it.″
The FDA had ordered an advisory board meeting in April to discuss the problems with Propulsid. That meeting has now been canceled.
Dr. Florence Houn of the FDA said that Propulsid had a unique action that was important to some patients. She said the pill triggered motility, a wave like action in the gut, that moved gastric acid away from the esophagus, thus preventing nighttime heartburn for some patients.
J&J said Propulsid sales were about $950 million worldwide last year but that it expects sales this year to drop to $250 million.
It was the second time this week that safety concerns prompted the FDA and a drug maker to act on a medication.
On Tuesday, a diabetes drug that has been linked to at least 61 deaths was withdrawn from the market after a review of safety data showed it was more toxic to the liver than comparable drugs. The FDA said that it requested that Rezulin, a drug for treatment of Type 2, or adult-onset, diabetes, no longer be sold. The agency said that Parke-Davis/Warner-Lambert, the drug manufacturer, agreed to the action.
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