The Food and Drug Administration (FDA) issued an updated warning regarding the drug cisapride (Propulsid), which is used to treat severe nighttime heartburn in patients with gastroesophageal reflux disease (GERD). The drug should not be given to patients with heart disease-related chest pain (angina), or those with heart arrhythmias or other cardiovascular problems.

The January 24 action was 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. An analysis of 270 reports of adverse events associated with the drug, including 70 fatalities, revealed that approximately 85% of these cases occurred in patients with identifiable risks.

The drug's sponsor, Janssen Pharmaceutical of Titusville, New Jersey, issued a letter to doctors advising them to give patients an electrocardiogram and blood tests prior to prescribing cisapride. Patients who are already taking the drug are encouraged to ask their doctors about having the recommended tests performed and whether they should pursue other treatment options, according to the FDA. FDA stresses that cisapride is contraindicated for patients with angina and for those on some antiarrhythmic agents, antiallergy agents, antibiotics, antifungals, antinausea, antipsychotics, and protease inhibitors. Other people who should not take the drug include those with history of irregular heartbeats, abnormal electrocardiogram (ECG or EKG), heart disease, kidney disease, lung disease, low blood levels of potassium, calcium or magnesium, eating disorder (such as bulimia or anorexia), dehydration or persistent vomiting.