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.