Propulsid Particularly Harmful to Children
May 20, 2001
Propulsid, a heartburn drug manufactured by Janssen Pharmaceutica, a Johnson & Johnson Co. subsidiary, is now banned. The removal of Propulsid came too late for many patients and unfortunately many of those who died were children. Propulsid, approved in 1993 and withdrawn from the market in July 2000, was shown to increase the heart's "QT interval," a potentially deadly side effect. An increase in the QT interval affects the heart's rhythm. Since Propulsid is used to treat heartburn, the FDA's investigators focused on the drug's gastrointestinal side effects and largely brushed off side effects associated with heart function.
Prolonging the QT interval can cause arrhythmias and sudden death. The FDA recognized the problem but chose to keep Propulsid on the market. The drug also became popular in the treatment of young children and babies who were often kept awake at night due to severe heartburn. Unfortunately, Propulsid's adverse effects on these young children were even less understood than its adverse effects on adults.
While Propulsid was never officially approved for young children, U.S. doctors are allowed to prescribe drugs in any manner they see fit. Since Propulsid was effective in helping relieve children's' heartburn, it was widely prescribed by pediatricians. Propulsid's manufacturer sought explicit approval from the FDA for use of the drug in children. In 1996 the FDA rejected Janssen Pharmaceutica's request for such approval. However, that rejection was not made public by the agency and pediatricians continued to prescribe Propulsid to their infant patients. It was not until 1998 that the FDA required a small warning label on Propulsid packages discussing possible adverse heart problems associated with children and Propulsid. The warning did little to inform doctors, as many admitted to being unaware of the label change.
"If I had known that this drug [Propulsid] caused cardiac arrhythmias, I would never have given it to him," said Tina Englebrick, mother of a three-month-old child who died after taking Propulsid. Some parents, including those of nine-month-old Gage Stevens who died after taking Propulsid, have sued the manufacturer, claiming that had they "been informed of a risk of sudden death, they would not have administered the medication to their son."
According to Dr. Robert R. Fenichel, retired deputy director of the FDA's cardiac drugs division: "It was scandalous that all these kids were being treated with [Propulsid]." With Propulsid's removal in 2000, over 300 people are said to have died because of the drug's tendency to increase the QT interval. Dr. Florence Houn of the FDA said in a statement regarding Propulsid that "the labeling probably was not effective."
Why did it take the FDA so long to act on Propulsid? The British explicitly warned doctors in 1998 about Propulsid's adverse effects on children.
-- Article Courtesy of InjuryBoard.com
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