Propulsid was approved by FDA in 1993. It was manufactured by Janssen pharmaceutical a subsidiary of Johnson and Johnson. Janssen discovered Cisapride in 1980. Cisapride is the main active ingredient of Propulsid. It started manufacturing and marketing Propulsid after FDA approval in 1993.

At the time of approval FDA asked Janssen to add an advise to the healthcare professional on the label of Propulsid. This advise to the doctors was related to rare cases of irregular heartbeats or Heart arrhythmia.

Soon after its production started, Propulsid was being linked to sever heart disorders including Heart arrhythmia and heart attack. By 1995, it was also considered as a concern by FDA. Dr. Stephen B. Fredd, who was a senior medical officer of FDA told Janssen on 25th January 1995, about Propulsid’s adverse reaction resulting in prolonged QT interval, which could lead to the death of patient.

On 24th January 2000 FDA issued a notification informing healthcare professionals about important changes in the Propulsid labeling. These changes involved new safety information about performing diagnostics tests prior to any use of Propulsid.

On 12th April 2000 FDA issued safety alerts, public health advisory and other notifications related to the fact that FDA approves medical products but it does not endorse any product or company. It issued safety alerts regarding use of Propulsid.

On 13th April 2000 it issued a notification informing healthcare practitioners and pharmacies about Janssen’s announcement of stopping the marketing of Propulsid in the United States as of July 14, 2000. It concluded that there was enough time for patients and doctors as well to arrange for any other treatment, which could replace Propulsid.

FDA issued a letter to healthcare professionals in April 2000. It stated that due to the risk of serious cardiac arrhythmias and death as a result of Propulsid side effects, Janssen Pharmaceutical with consultation of FDA has decided to stop marketing its drug Propulsid in U.S. as of 14th July 2000.

It informed that serious cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation and QT prolongation have been linked to use of Propulsid.

It stated that though Janssen has implemented labeling changes and sponsored educational programs to help assure the safe and appropriate use of Propulsid for last few years but risk related to this drug has not reduced as desired. This fact has led Janssen pharmaceuticals to stop marketing of this drug in U.S. as of 14th July 2000. This drug would be available only through an investigational limited access program. This program would be only for treatment of those patients, who have failed to find out other treatment options. It drafted an eligibility criterion for both patients and doctors to access the investigational limited access program. Adult patients who have Gastro esophageal reflux disease (GERD), gastro paresis, pseudo-obstruction, and severe chronic constipation and could not find any other treatment option. Children having refractory GERD, which is associated with failure to thrive, asthma, bradycardia, apnea, or other serious conditions or pseudo-obstruction and not able to find an alternative treatment option.