Product Liability Law - Propulsid March 26, 2009.

Propulsid was supposedly designed to solve acid reflux; instead its side effects caused fatal heart rhythm abnormalities.

This drug was made by Janssen Pharmaceutical and was supposed to handle nighttime heartburn by moving food out of the stomach, and keeping acid away from the esophagus. It was approved by the Food and Drug Administration (FDA) in 1993, and was marketed as being able to tighten the valve between the esophagus and the stomach.

For three years there was no warning label about the drugs effect on people’s heart rhythms. Then adverse event reports began coming in, prompting Janssen Drugs to warn people they could die from taking Propulsid. The drug was finally taken off the market in 2000. Taking it off the shelves affected over 350,000 Americans taking it. Over 30 million people had taken the drug since 1993.

Up until 2000, when it was taken off the market, the FDA received approximately 341 reports of serious heart problems and at least 80 deaths. Those stunning figures are what prompted the drug recall. It was approved for use only with adults, but it appeared infants and premature babies got it as a treatment for colic. Of the 80 deaths, 11 were children and 20 of the 341 adverse reactions were little ones with nonfatal heart irregularities.

Other damning evidence leaked out about this drug while it was still being marketed. Facts included information that it reacted badly to other drugs, and should not have been taken with allergy medicines, antidepressants, medicines for irregular heart rhythms, antibiotics, etc.
Propulsid side effects included sudden death, heart attacks, heart rhythm disorders, seizures, hepatitis, thrombocytopenia, and aplastic anemia, etc.

Lawsuits indicate the drug company didn’t perform proper safety studies that would have told them this was a dangerous drug. There were also allegations that the FDA didn’t reveal research that indicated the drug was flawed, because how it worked was supposedly a trade secret.

If you have any questions about having taken Proplusid/Cisapride, or about your legal rights when it comes to taking dangerous drugs, contact a dangerous product attorney who will advise you on how to proceed.