Heartburn Medication Linked to Heart Rhythm Abnormalities and Death
Propulsid, a popular medication for severe gastroesophageal reflux disease (GERD) was pulled from the market as of July 14, 2000 after being linked to 341 reports of heart rhythm abnormalities. At least 80 wrongful deaths have been linked to Propulsid, also known as cisapride. This action by the manufacturer follows a January 24, 2000 warning by the Food and Drug Administration in which users were advised to be tested to determine whether heart damage had been sustained. Although Propulsid was not approved for use in babies, it is reported that its use in babies to treat reflux had become widespread, and some cardiac arhythmias and deaths resulted. Of the 80 wrongful deaths linked to Propulsid, 11 were babies. In one study of 58,000 premature babies' medical records, it was found that 20% were given Propulsid.
Most of the adverse events occurred in patients who had preexisting medical conditions or were taking other medications such as Biaxin, an antibiotic; Serzone, an antidepressant; Diflucan, Nizoral or Sporanox, antifungals; and Crixivan or Norvir, protease inhibitors. The drug is also contraindicated in patients with congestive heart failure, a history of ventricular arrhythmias, ischemic heart disease, multiple organ failure, chronic obstructive pulmonary disease, and advanced cancer.
The night time heartburn drug is manufactured by Janssen Pharmaceutica, a subsidiary of Johnson & Johnson. Propulsid was originally approved by the Food and Drug Administration in 1993 and was one of Johnson and Johnson's top selling drugs. The company is initiating a limited access program to make the drug available to patients who meet clearly defined eligibility criteria and for whom other therapies are not effective. Because of the risks associated with Propulsid and the many factors that need to be considered in prescribing it, the FDA has advised doctors to use the drug in patients who have not responded to other drug therapies or lifestyle modifications.
The Stipe Law Firm is representing several hundred people who have taken Propulsid. If you have had a family member die or suffer serious heart problems while taking Propulsid, please contact us online or at 1-800-522-8522.
