Propulsid is a prescription drug developed by Janssen Pharmaceutica of Titusville, N.J. for the treatment of nighttime heartburn. It is marketed by its parent company, Johnson & Johnson, and has been generally available since July 1993 when it was first approved by the Food and Drug Administration. Since then, it has been used by more…
The FDA has advised doctors about new warnings of cardiac problems associated with Propulsid. They have told Janssen to revise the label to include new information about the cardiac risks associated with the drug and to recommend that other therapies for heartburn generally be used before prescribing Propulsid. Five times between the date the drug…
Propulsid was found to cause heart rhythm abnormalities, resulting in various other medical problems and sometimes death. Patients with no history of cardiac problems were subjected to new difficulties that were caused either by a combination of the drug with antibiotic and antifungal drugs, or through a combination of illnesses. Some of the effects of…
A very small proportion of those who used the drug had problems with it. However, there were 341 reports of significant heart difficulties, of which 80 resulted in death. This number is out of 30 million patients who used the drug at some time.
The approval of Propulsid by the FDA had been only for adult use. A study of approximately 58,000 premature babies showed that about 20 percent of mothers had been given Propulsid. Presently, approximately 11 infant deaths have been associated with Propulsid use. Many doctors used Propulsid to treat babies with heartburn-causing ”gastroesophageal reflux.” This reflux…
Yes. Patients at higher risk included those who were using conflicting drugs, or who had conflicting disorders such as a history of cardiac problems. Patients who used the drug alone, with no alternative therapy or conditions, generally suffered no adverse effects.
If Propulsid has caused you or a loved one significant physical damage, you may be entitled to compensation. Contact us at Younce, Vtipil, Baznik & Banks, P.A., to evaluate your rights. It will cost you nothing to speak with an attorney about your potential claim and there is no obligation when you call.
After years of escalating fatalities and pressure from the FDA, Janssen announced that it would voluntarily stop marketing Propulsid in the United States beginning July 14, 2000. The drug is still used for treatment. However, patients must now meet an even more stringent level of criteria. Physicians must assess each patient and then confirm that…
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