Propulsid has been linked to 80 deaths since 1993 and a variety of serious cardiac problems in hundreds of patients.
CBS News Correspondent Elizabeth Kaledin reports Propulsid is a unique drug which worked wonders for a small group of people like Bernard Schwartz.
"When I first started to take it I was in severe pain," Schwartz explains. "I had real trouble, I had very bad reflux and I couldn't control it."
The company will no longer distribute the drug to pharmacies after July and will only make it available to a limited number of patients who fail other therapies. The "limited-access" program will begin May 1.
Propulsid had $950 million in sales last year, but with the new restrictions, Johnson & Johnson estimates the drug will generate just $250 million in sales this year. Propulsid has already had $150 million in sales in the first quarter of 2000, Johnson & Johnson said.
Patients now taking Propulsid are advised to speak with their doctors.
The FDA approved Propulsid, one of Johnson & Johnson's top selling drugs, 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.
"Propulsid remains safe and effective for the vast majority of patients when used according to the approved prescribing information," Johnson & Johnson said. The drug is made by Johnson & Johnson's Janssen Pharmaceutica subsidiary.
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.
Johnson & Johnson 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 fom the esophagus, thus preventing nighttime heartburn for some patients.
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 Warner-Lambert, the drug manufacturer, agreed to the action.
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