FDA: Stronger warnings for Propulsid

March 1, 2000

Pharmaceutical Representative

The Food and Drug Administration is warning patients taking Titusville, NJ-based Janssen Pharmaceutica's heartburn treatment, Propulsid® (cisapride) of new advisories concerning the drug. Propulsid is a treatment for severe nighttime heartburn in patients with gastroesophagal reflux disease who do not adequately respond to other therapies. The new measures are being recommended to help physicians avoid giving Propulsid to patients who are at known risk of rare, but serious, cardiac events associated with the drug.

The actions were prompted by continued 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. A recent analysis of 270 adverse event reports, including 70 fatalities, revealed that approximately 85% of these cases occurred in patients with these identifiable risks.

In response to the FDA's findings, Janssen has issued a "Dear Healthcare Professionals" letter summarizing updates being made to the warnings and precautions section of the drug's label. Changes include the recommendation that physicians perform an electrocardiogram and certain blood tests prior to prescribing the drug.

The revised label also includes a list of the contraindicated drugs and underlying conditions that put patients at increased risk. Propulsid should not be given to patients taking certain types of the following medications: anti-allergy, anti-angina, anti-arrhythmics, antibiotics, anti-depressants, anti-fungals, anti-nausea, anti-psychotics and protease inhibitors.

Propulsid was approved by the FDA in tablet formulation in 1993 and in suspension formulation in 1995. Patients who are currently taking the drug are encouraged to ask their doctors about having the recommended tests performed and whether they should pursue other treatment options.PR

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