FDA Information

Cisapride was approved by FDA in tablet form in 1993, and then in suspension form in 1995.

Cisapride is a treatment for severe nighttime heartburn in patients with gastroesophageal reflux disease (GERD) who do not adequately respond to other therapies. 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.

In many countries it has been either withdrawn or has had its indications limited due to reports about long QT syndrome due to cisapride, which predisposes to arrhythmias, about which the FDA issued a warning letter to health care professionals and patients.

Please visit the official site of the FDA for further information.

 

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