Some 30 million U.S. residents, including former President Clinton, have taken Propulsid since it hit the market in 1993 for Gastroesophageal Reflux Disease (GERD). Propulsid, also known as Cisapride, may cause irregular heartbeats and even sudden death. At least 341 reports of heart-rhythm abnormalities, including 80 reports of deaths, have been associated with Propulsid.
After the drug's approval in 1993, there were several revisions to Propulsid's label, informing health care professionals and patients about various side effects and risks, the most serious of which involved rhythm irregularities (arrhythmias) and cardiac arrest in people with no prior heart disease.
After years of escalating fatalities and pressure from the FDA, Janssen Pharmaceutical Inc., the manufacturer, announced that it would voluntarily stop marketing Propulsid in the United States beginning July 14, 2000. In September 2001, a $1.2 billion trial began against the manufacturer of Propulsid.