Cardiac contraindications included in new FDA warnings about Propulsid

January 25, 2000

Jan 25, 2000Cardiac contraindications included in new FDA warnings about PropulsidWashington, DC- The Food and Drug Administration yesterday released updated warnings to physicians and patients concerning the use ofcisapride(Propulsid). The agency wishes to avoid its use in patients either taking certain drugs concomitantly or who have underlying conditions, such as heart disease, that appear to increase their risk for adverse events. The drug is used in the treatment of night-time heartburn in gastroesophageal reflux disease (GERD) in patients who have failed other therapies.Recent analysis of 270 adverse event reports, including 70 fatalities, showed 85% of the events occurred in patients with identifiable risks. The FDA concluded that patients should not be prescribed cisapride if they are taking any of the following medications:Anti-allergy medicationsAnti-arrhythmicsAntidepressantsAntifungalsAntinausea agentsAntipsychoticsProtease inhibitorsNor should they take the drug if they have a history of any of the following:ArrhythmiasAn abnormal EKGHeart diseaseKidney diseaseLung diseaseLow serum potassium, calcium, or magnesiumAn eating disorder such as anorexia or bulemiaDehydrationPersistent vomitingChanges to the label - which have been outlined in a "Dear Health Professionals" letter also issued today byJanssen Pharmaceutica(Titusville, NJ) - include recommendations that an EKG be performed before the drug is prescribed and that electrolyte testing be carried out. Patients already on the drug are counseled to ask their physician to see if they should have these tests or perhaps pursue other treatment options.A previous warning about cardiac risks associated with the drug was issued in 1998 (see FDA Talk Paper T98-39). The FDA also announced a public advisory committee meeting for April 12, at which time the safety of the drug is to be discussed further.Susan JeffreyRelated linksFDA MedWatch websitewww.fda.gov/medwatchJan 24, 2000 letter from Janssen Pharmaceuticahttp://www.fda.gov/medwatch/safety/2000/propul.htmTue, 25 Jan 2000 22:37:08

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