Propulsid®

Because of the risk of serious cardiac arrhythmias and death associated with the use of Propulsid® in certain patients, Janssen, in consultation with the FDA, has decided to discontinue marketing Propulsid® as of July 14, 2000 and make it available only through an investigational limited access program. Propulsid® has been associated with serious cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation. From July 1993 through December 1999, 341 such cases have been spontaneously reported, including 80 deaths. In approximately 85% of these cases the events occurred when Propulsid® was used in patients with known risk factors.

Over the past few years, Janssen has implemented labeling changes and sponsored educational programs to help assure the safe and appropriate use of Propulsid®. However, the level of adverse event reporting and risks associated with the drug did not sufficiently decrease.

Source: fda.gov

If you or a loved one has been harmed by Propulsid®, you may want to contact a Propulsid® attorney for more information.