Propulsid is a prescription drug manufactured by Johnson & Johnson and marketed by Janssen Pharmaceutical. Propulsid's approved usage is for severe nighttime heartburn experienced by adults with gastroesophageal reflux disease that does not respond to other therapies. Since its approval in 1993, there have been 341 reports of heart rhythm abnormalities including 80 reported deaths. This drug is also associated with serious cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, torsades de pointes and QT prolongation. These adverse effects are primarily experienced by users taking certain other medications or who have certain underlying conditions that were known risk factors.

Propulsid was initially offered on the market in the United States in July 1993. In June of 1998, Janssen sent a letter to physicians announcing labeling changes that placed more emphasis on (a) contraindications for use in combination with other drugs, (b) adverse effects in patients having disorders that predispose them to arrhythmias, and (c) precautions for pediatric use. The letter also acknowledged a number of previously "unlabeled" potentially serious events in pediatric use. In January of 2000, the boxed warning for this drug was changed, advising doctors to perform certain diagnostic tests prior to prescribing the drug and to avoid giving the drug to patients with known risk of rare cardiac events. Patients already on the medication were advised to undergo the same diagnostic tests. In April 2000, another physician letter was issued that explained the manufacturer's intent to discontinue marketing and described the protocol that had been established for participation in an investigational program. On July 14, 2000, Janssen Pharmaceutical, in consultation with the Food and Drug Administration, discontinued marketing in the United States. Propulsid will be made available only through an investigational limited access program.

If you would like to speak with someone concerning Propulsid, you may discuss your particular situation with an experienced attorney at the law offices of LeBlanc & Waddell by telephone at 800-988-3514, by fax at 225-768-7999, or by contacting us online.