Propulsid - Urgent FDA Warning

Cisapride (Propulsid) is a drug that is commonly used in the treatment of heartburn in patients with gastroesophageal reflux disease (GERD). It has been on the market in the U.S. since 1993. It has now been found to be the cause of dangerous heart irregularities. All patients taking the drug should contact their doctors immediately. The following warning by the Food and Drug Administration (FDA) explains why.

-- Medical Editor,

The Food and Drug Administration (FDA) is advising health care professionals and patients of important new information, including recommendations for performing diagnostic tests, that should be considered prior to any use of the drug cisapride (Propulsid). Cisapride is a treatment for severe nighttime heartburn in patients with gastroesophageal reflux disease (GERD) who do not adequately respond to other therapies. The new measures are being recommended to help physicians avoid giving cisapride to patients at known risk of rare-- but serious--cardiac events associated with the drug.

As part of an ongoing risk management effort, FDA is also announcing a public advisory committee meeting to be held on April 12, where the safety of the drug and additional methods to reduce the occurrence of adverse events will be discussed.

Meantime, patients who already take the drug are encouraged to ask their doctors about having the recommended tests performed and whether they should pursue other treatment options.

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. 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.

The new risk management measures are being announced in conjunction with a "Dear Healthcare Professionals" letter issued today by the drug's sponsor, Janssen Pharmaceutica of Titusville, NJ, that summarizes the updates being made to the warnings and precautions sections of the drug's label. The changes include recommending that physicians perform an electrocardiogram and certain blood tests prior to prescribing the drug.

The revised labels also list the contraindicated drugs and underlying conditions which put patients at increased risk. Cisapride should not be used by patients taking some of the following types of medications: anti-allergy, anti- angina, anti-arrhythmics (irregular heart rhythm), antibiotics, anti-depressants, anti-fungals, anti-nausea, anti-psychotics and protease inhibitors (anti-HIV infection).

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