New York Propulsid Injury Lawyers

Propulsid, also known as Cisapride, is a prescription drug prescribed to treat nighttime heartburn caused by Gastro Intestinal Reflux Disease which happens when stomach acid backs up and causes heartburn. Manufactured by Janssen Pharmaceutica, and marketed by Johnson and Johnson, Propulsid was first introduced in the U.S. in July 1993, serious safety concerns surfaced shortly after the drug's approval.

Since Propulsid is a digestive drug, the FDA's gastrointestinal unit was required to review its effectiveness and safety. While the doctors in this unit (experienced in evaluating drugs only as they relate to digestive conditions) felt that there may be some very mild heart related side effects associated with Propulsid, they did not feel they warranted asking the doctors in the FDA's cardiovascular unit to evaluate the drug. This oversight proved to be a fatal mistake.

Propulsid was removed from the market in March 2000, after the FDA found that at least 300 people died as a result of taking the drug. It is likely that the numbers are much higher, as many deaths could have gone unreported. Additionally, prior to the recall, FDA failed to inform doctors that Propulsid could prove especially deadly for children. Infants often suffer from gastric reflux that interrupts their sleep patterns.

Doctors found that Propulsid was especially effective in reducing gastric reflux in infants. Many children were prescribed Propulsid without adequate warnings and several children died following ingestion of the drug. Parents and doctors had no way of knowing that Propulsid was not safe for children. The FDA first recognized Propulsid's danger to children in 1996, yet pediatricians were not informed of the possible risks until the drug's label was changed in 1998. Propulsid has now been linked with the development of Sudden Infant Death Syndrome (SIDS), and with ventricular tachycardia, ventricular fibrillation, and torsades de pointes prolongation. Numerous individual claims, national lawsuits and class actions have been filed involving Propulsid.