J&J Propulsid
Executive Summary
Investigational limited access program for Janssen's cisapride will begin May 1 for three treatment protocols of patients who have failed all other standard therapies, an April 12 "Dear Doctor" letter states. The protocols include: adults with gastroesophageal reflux disease, gastroparesis, pseudo-obstruction and severe chronic constipation; pediatrics with pseudo-obstruction or refractory GERD associated with failure to thrive, asthma, bradycardia, apnea or other serious conditions; and neonates with feeding intolerance. The protocols require electrocardiograms every three months for adults and every two months for outpatient pediatric patients. Public Citizen's Health Research Group has asked for a complete withdrawal of the drug, reporting that 103 deaths were associated with Propulsid between Dec. 31 and March 28. J&J announced March 23 it will limit access to the drug due to cardiac events (1"The Pink Sheet" March 27, p. 3)