Propulsid is used to treat severe heartburn. Heartburn, or "gastric reflux," occurs as acid from the stomach is regurgitated into the esophagus. Stomach acid is supposed to remain in the stomach. However, when it fails to do so, the sensation commonly referred to as heartburn occurs.
Propulsid, approved by the FDA in 1993 and manufactured by Janssen Pharmaceutica, a Johnson & Johnson Co. subsidiary, prevents heartburn by causing the stomach, intestines, and esophagus to operate faster during digestion. While Propulsid is very effective at relieving heartburn, serious safety concerns surfaced shortly after the drug's approval.
Since Propulsid is a digestive drug, the FDA's gastrointestinal unit was required to review its effectiveness and safety. The doctors in this unit, while experienced in evaluating the efficacy of drugs as they relate to digestive conditions, are not as experienced in assessing the effect of digestive drugs on other parts of the body. While the doctors in the digestive division felt that there may be some very mild cardiovascular (heart related) side effects of Propulsid, they did not feel the negative aspects warranted asking the doctors in the FDA's cardiovascular unit to evaluate the drug. This oversight proved to be a fatal mistake.
In March 2000 the FDA removed Propulsid from the market after finding that at least 300 people, and likely many more (whose deaths went unreported), died after taking the drug. Additionally, prior to the recall, FDA failed to inform doctors that Propulsid could prove especially deadly for children. Infants often suffer from gastric reflux that interrupts their sleep patterns. Doctors found that Propulsid was especially effective in reducing gastric reflux in infants. The FDA first recognized Propulsid's danger to children in 1996, yet pediatricians were not informed of the possible risks until the drug's label was changed in 1998.
Use of Propulsid has subsequently been shown to increase what doctors refer to as the QT interval. The QT interval measures the time it takes the heart muscle to expand and contract. A healthy QT interval is around 4/10 of a second. A slight increase in that time can interrupt the heartbeat and cause an arrhythmia, resulting in immediate death.
In February 2004, Johnson & Johnson agreed to pay up to $90 million to settle claims made by 4000 plaintiffs who say Propulsid caused heart problems.
See your doctor if you have experienced serious side effects associated with Propulsid. In addition, it may be important to contact an attorney who can help you protect your legal rights. To date, many Propulsid victims have filed suit against Johnson & Johnson and its subsidiary, Janssen Pharmaceutica. Please keep in mind that there may be time limits within which you must commence suit.