NEW YORK (Jan. 24) - The Food and Drug Administration said on Monday it had issued a warning to doctors about possible dangers of Johnson & Johnson's treatment for heartburn, Propulsid, following reports of scores of fatalities among users of the medication.

The U.S. Food and Drug Administration said it acted after analyzing 270 reports of adverse events, including 70 fatalities, among people who have taken the drug since it was launched in 1993. The agency said about 85 percent of the cases involved patients with identifiable risks.

J&J does not disclose sales of individual drugs. But some analysts have estimated that Propulsid's global 1999 sales approached $1 billion, making it the New Jersey drugmaker's third biggest-selling pharmaceutical.

''Today's actions are prompted by continuing reports of heart rhythm disorders and deaths associated mostly with the use of the drug in people who are either taking certain other medications or who have certain underlying conditions that are known risk factors,'' the FDA said.

The FDA said that because of the reports, the medicine's insert label will be changed to require that doctors perform an electrocardiogram and various blood tests prior to prescribing it.
The label change will state that Propulsid should not be used by patients already taking certain types of medicines for allergies, angina, nausea and irregular heart rhythm as well as those taking certain types of antibiotics, anti-depressants, antifungals, anti-psychotics and protease inhibitors against the HIV virus.
 

J&J said the antidepressants which should not be taken with Propulsid include the entire class of older therapies known as tricyclics, while the forbidden antibiotics include three members of the macrolide family -- including erythromycin.

 Moreover, the FDA said it also advised that patients not take Propulsid if they have a history of irregular heartbeat, abnormal electrocardiograms, heart disease, kidney disease, lung disease, low blood levels of potassium, calcium or magnesium, eating disorders, dehydration or persistent vomiting.
 

Propulsid (cisapride), which was approved by the FDA in tablet form in 1993 and in suspension form in 1995, is sold by J&J's Janssen Pharmaceutica unit.
 

The medicine is used to treat severe night-time heartburn for patients with gastroesophageal reflux disease (GERD) who do not adequately respond to other therapies.
 

In patients with GERD, acid and stomach contents back up into the esophagus, causing heartburn and other symptoms. Persistent heartburn can lead to esophageal cancer.
 

Jannsen spokesman Greg Panico declined to speculate how seriously Propulsid's sales would be hurt by the FDA warning letter, the label changes and the newly mandated medical tests. ''its on the market and helping people,'' Panico said, adding that it would remain on the market.
 

''Our drug is safe, when used appropriately. But after any label change there is some dropoff in a drug's sales,'' he said. Panico added that the 270 adverse event reports stretched out over a 7-year period, during which time he said 30 million prescriptions for the drug had been written in the United States.

 

One Wall Street analyst, who asked not to be identified, said he believed the FDA warning and required medical tests would ''decimate'' sales of Propulsid.
 

''With the FDA warning, Propulsid is no longer a drug of choice for GERD. Its sales could be driven down to the $200 million or $300 million (annual) range, at which point Johnson & Johnson might decide to pull the drug from the market,'' the analyst said.
 Johnson & Johnson late last year began marketing an ulcer drug, Aciphex (rabeprazole), that is also approved for GERD. Some patients now taking Propulsid might switch over to Aciphex, although Aciphex has a different mechanism of action, analysts said.
 Aciphex is a so-called proton pump inhibitor, a class of ulcer drugs that help limit production of gastric acids. Another proton pump inhibitor also approved for GERD, Prevacid (lansoprazole), is sold by a joint venture between Illinois-based drugmaker Abbott Laboratories and Takeda Chemical Industries Ltd of Japan.

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