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Ashcraft & Gerel
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PROPULSID - HEARTBURN MEDICATION LINKED TO HEART RHYTHM ABNORMALITIES AND DEATH
[Introduction: Although our offices are located in Maryland (MD), Virginia (VA) and Washington, D.C. (DC), our drug and pharmaceutical practice is national in scope, and our lawyers are handling many drug cases around the country. Therefore, regardless of what state you're in, please complete our inquiry form on this web site or email us so that we can have an attorney from our drug litigation department contact you.
We're sorry, but we are
no longer accepting new Propulsid claims.]
Propulsid, a popular medication for severe gastroesophageal reflux disease (GERD) will be pulled from the market as of July 14, 2000 after being linked to 341 reports of heart rhythm abnormalities. At least 80 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 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. Patients who are now using Propulsid are advised to consult with their physicians.
The company's voluntary action was taken following "consultations" with the FDA. An FDA public advisory committee meeting scheduled for April 12, 2000 to discuss ways to reduce the incidence of adverse events associated with Propulsid was canceled.
Ashcraft & Gerel is now accepting claims for injuries caused by Propulsid. We have been a leader in mass tort and product liability cases and settlements, including Rezulin, asbestos, breast implants and tainted blood. Our lawyers have been at the forefront of the Fen-Phen diet drug claims for over two years, and we are well situated to see the Propulsid cases to a successful damage recovery for our clients. We have a toll free number to answer your questions with regard to your specific case. That number is (800) 725-6470. If you would prefer, please feel free to e-mail us or complete the help inquiry form on this web site. Please be sure to include your name, address, telephone number (if you wish to be called), email address and the exact nature of your question so that we can provide you with the specific information you seek.
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