Propulsid Recall

NEWSFLASH REGARDING CISAPRIDE (PROPULSID)…

Beginning July 2000, Janssen Pharmaceutica will no longer be marketing cisapride (Propulsid). This comes in consultation with the FDA following the report of 341 cases of serious cardiac arrhythmias (irregular heart rhythms) in adults and children over a 3 1/2 year period. 80 of these cases resulted in death. Most of these cases occurred in patients with known risk factors.

Cisapride will still be available on an investigational bases. This means that physicians may still obtain cisapride for patients under strict guidelines. In pediatrics, only children with serious complications from reflux and who are unresponsive to other therapies will be considered. Serious complications include asthma, failure to thrive (stunted growth), bradycardia (slowing of the heart), and apnea (cessation of breathing). Pediatric patients with pseudo-obstruction and neonates with feeding intolerance may also be considered. Children who are receiving the investigationally dispensed cisapride must be followed by a GI (gastrointestinal) specialist in addition to their regular doctor. Routine monitoring of laboratory tests and EKGs will be required.

For most patients, this will mean that cisapride will no longer be available as a treatment option. Supportive measures such as positioning and formula thickening (as described in the Infant Reflux article by Dr. Greene) are recommended. There are a number of other options available if needed.