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All About Propulsid

Propulsid (Cisapride) is a prescription drug manufactured by Janssen Pharmaceutica, and marketed by Johnson and Johnson. The principal ingredient in Propulsid is the chemical compound Cisapride. Propulsid was first approved as a new drug by the Food and Drug Administration (FDA) in July 1993. Propulsid is prescribed to treat nighttime heartburn caused by Gastro Intestinal Reflux Disease which happens when stomach acid backs up and causes heartburn. The heartburn can be relieved promptly by antacids, but the relief is shortlived.

From July 1993 when Propulsid first came to market, until February 1995, Janssen had no warning on its labeling with regard to the drug's effect on cardiac rhythm. The labeling should have had such a warning because as far back as 1989 the World Health Organization was reporting that Cisapride was associated with disturbances in heart rhythm. Disturbance in heart rhythm means the electrical activity of the heart is not normal. Abnormal electrical heart problems can range from simply fainting to sudden death. In six cases where Cisapride was prescribed at doses below or equal to the recommended dose, occurences of heart rhythm disturbance continued for 15 days. And as soon as Cisapride treatment was withdrawn, the heart rhythm in each case returned to normal. Other medical journals between 1988 and 1991 published articles associating Cisapride treatment with abnormal heart rates up to 130 beats per minute, a rate which strains the heart and which over time may cause an early death. In one case a 64 year old male with a normal heart and no history of cardiac rhythm irregularities or seizure disorder, after receiving cisapride, fainted. The doctors related this fainting episode to an irregular heart beat seen on an abnormal ECG. In 1993 Janssen began to receive adverse reaction reports related to the use of Propulsid. These are reports from doctors documenting a bad reaction to a product, here Propulsid. Janssen responded by sending a letter to all physicians in the United States warning them not to prescribe Cisapride to patients taking anti-fungal drugs or anti-biotic drugs, such as eyrthomycin and to use caution when prescribing Cisapride to patients with renal insufficiency, or a history of arrhythmia and cardiac disease. Combining an anti-biotic with Cisapride increases the risk of developing a heart rhythm abnormality or even sudden cardiac death.

By July 1996, the New England Journal of Medicine reported that the FDA had received reports of persons receiving cisapride, 4 of whom had died and 16 who responded to resuscitation after their heart stopped . It was not until June 1998 that Janssen issued a letter to all physicians warning that even in the absence of taking other drugs, cardiac arrest and sudden death have been reported in patients taking Propulsid. By December 1999 there were 341 reported cases of serious cardiac rhythm disturbances and the deaths associated with use of Cisapride had risen to 80. The truth is this prescription drug for heartburn has the potential side effect of causing serious heart disorders. Further the reader should understand the FDA recognizes that underreporting of adverse experiences is widespread and that the exact number of serious adverse events associated with the Propulsid may be at least 10 times more than is reported.

If you or a loved one have suffered from documented cardiac arrhythmias associated with the use of Propulsid, call us at (800) 220-LAW1, or use the "Do I Have A Case?" link on this web site.

This informational piece was prepared by Silverman & Fodera. If you would like more information on this topic, call us at (800) 220-LAW1, or use the "Do I Have A Case?" link on this web site.