Propulsid, also known as cisapride, was a drug prescribed to infants, children, and adults for severe heartburn or gastroesophageal reflux disease (GERD). Propulsid was manufactured by Janssen Pharmaceutica, a subsidiary of Johnson & Johnson. The drug was approved by the FDA in 1993. Propulsid was one of Johnson & Johnson’s most successful products, and it is estimated that as many as 30 million Americans have taken the drug since 1993. On July 14, 2000, Propulsid was pulled from the U.S. market due to safety concerns. The drug is currently available only to patients who meet the stringent requirements of the manufacturer’s limited access program.
What health problems have been associated with Propulsid?
As of December of 1999, there had been 341 reports of heart rhythm abnormalities associated with Propulsid including 80 deaths. These serious cardiac arrhythmias include ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation. Many of the adverse reactions were in patients who were taking other medications at the same time as Propulsid such as medications for allergies, angina, heart rate irregularities, fungal infections, depression, nausea, protease inhibitors, and antibiotics. In addition, the FDA warned earlier this year that Propulsid should not be used in patients with a history of irregular heartbeats, abnormal electrocardiograms (EKG or ECG), heart disease, kidney disease, lung disease, eating disorders, dehydration, or persistent vomiting.
In January of 2000, the FDA issued warnings against the use of Propulsid in infants after a study showed that a staggering 20% of 58,000 premature infants studied had been given Propulsid. Of the 80 deaths currently associated with Propulsid, at least 11 were infants.
What Symptoms Should I Be Concerned About?
Heart rhythm irregularities can be easily detected by an electrocardiogram (EKG or ECG) or by a 24-hour Holter monitor. If you have any of the following symptoms, you should consult with your physician to determine whether you have been injured:
- Chest Pain
- Rapid Heart Beat
- Shortness of Breath
How Can I Protect My Rights?
The law firm of Alley, Clark & Greiwe is currently accepting Propulsid cases. If you or a loved one have taken Propulsid in the past and believe that you have been injured, please contact us for a consultation regarding your legal rights. There are statutes of limitations that have already begun with respect to your claim, so please do not delay in taking steps to protect your right to pursue a claim.