The labeling for cisapride has been strengthened to include a recommendation to perform a 12-lead electrocardiogram in every patient before prescribing the heartburn drug.
Patients with QTc intervals longer than 450 milliseconds should not take the drug, according to a Dear Doctor letter issued by Janssen Pharmaceutica in late January. Cisapride, which is marketed by Janssen under the trade name Propulsid, is approved for the symptomatic treatment of nocturnal heartburn caused by gastroesophageal reflux disease.
The revised labeling was spurred by the continued reports of arrhythmias 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, the Food and Drug Administration said in a statement announcing the warnings.
From July 1993 through May 1999, more than 270 cases of ventricular arrhythmias have been reported in patients on cisapride, according to the new label. In 70 of these cases, the arrhythmia was fatal.
Other important revisions in the labeling include the recommendation to check serum electrolytes in patients on diuretics before prescribing cisapride and periodically thereafter. The drug is also now contraindicated in people with hypokalemia, hypocalcemia, and hypomagnesemia, which increase the risk of arrhythmias in people on cisapride.
COPYRIGHT 2000 International Medical News Group
COPYRIGHT 2001 Gale Group
Contact
Home
A
Cabergoline