The Food and Drug Administration is urging doctors to try everything else before prescribing Propulsid, a heartburn drug taken by President Clinton, out of concern the drug may cause serious heart problems.
The FDA ordered strengthened warnings for Propulsid Monday after reports of heart rhythm abnormalities, including 38 deaths, since the pill hit the market in 1993.
The FDA said it cannot prove the drug caused any deaths but noted that Propulsid already was known to cause irregular heartbeat rhythm, known as heart arrhythmia, when taken together with certain other medicines.
Monday’s action strengthens those warnings, adding newly discovered drug interactions and a list of other illnesses that increase the risk.
The drug’s manufacturer, Titusville, New Jersey-based Janssen Pharmaceutica, wrote thousands of doctors and pharmacists Monday to alert them to the strengthened warnings.
The letter says Propulsid should not be used in patients taking certain antibiotics, antidepressants, antifungals, protease inhibitors, or various other drugs.
Nor should it be taken by patients with certain disorders such as congestive heart failure, multiple organ failure, kidney failure, chronic obstructive pulmonary disease which causes serious respiratory problems, and advanced cancer.
Patients with severe dehydration, vomiting, diarrhea or malnutrition, or some patients taking diuretics or insulin should also not be given the drug.
Propulsid, known generically as cisapride, is usually prescribed for nighttime heartburn.
Clinton has taken Propulsid to control acid reflux, as well as another heartburn drug, omeprazole, according to reports of a physical in October. There was no indication that he uses any of the drugs that could cause problems when taken with Propulsid.