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PROPULSIDDESCRIPTION: Propulsid is the U.S. trade name for cisapride, a drug used to treat acid reflux, also known as gastro-exophageal reflux disease, or GERD. The drug was sold in the U.S. by Janssen Pharmaceutica Inc., a subsidiary of Johnson & Johnson. The same drug, with the trade name of Prepulsid was sold by Janssen-Ortho, Inc., in Canada. It was sold by many other trade names in over 120 countries. Since the drug's approval by the FDA in 1993, labeling has been revised four times to inform health care professionals and patients about growing concerns regarding the drug's risks of serious adverse cardiac events, especially when given in combination with the numerous other drugs with which it interacts. By April 2000, 103 deaths were reported, including a number of children. The manufacturer announced its decision to stop marketing Propulsid in the U.S. in March 2000. Today, apart from a limited accessibility program, the drug is no longer available in the U.S. or Canada. Meanwhile, morbidity and mortality statistics have continued to grow. Due to underreporting, it is believed that the numbers are much, much higher. Those who have sued the manufacturer claim the company mishandled its testing, marketing, promotion, labeling and/or post-marketing surveillance of the drug. Some suits include physicians, challenging their decision to prescribe Propulsid – especially for pediatric patients, for whom no safe dosage was ever determined – or the physician's work-up or monitoring of the patient. There is an MDL in place in the Eastern District of Louisiana (Judge Eldon Fallon, MDL 1355). There are class actions seeking medical monitoring in several states. Hundreds of individuals cases are filed. |
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