Documents Reveal Dangers of Propulsid

By Erik Ricasa

Published on July 22, 2005

Recently acquired documents from both Johnson & Johnson and the US government are showing that Propulsid, the once-popular heartburn drug, may have caused severe heart problems in some patients.
Though the company did not pull Propulsid from the market until 2000, the documents show that Johnson & Johnson held discussions with federal authorities in 1998 about the possible need to remove the drug from the market. This did not happen; instead, new warnings for Propulsid's label were agreed on.
Premature infants were most at risk during this two-year period. At one point, it is estimated that up to one in five babies in intensive care were being treated with Propulsid for acid reflux. Despite growing concerns about heart injury and possible death, Johnson & Johnson continued to portray the drug as being safe for children as well as adults.
According to the latest available lawsuit documents, Johnson & Johnson declined to conduct safety studies of Propulsid that would have shown the heart injury risks, even when urged to do so by both federal regulators and corporate consultants. The Food and Drug Administration, due to concerns of releasing trade secrets, did not divulge Johnson & Johnson research that raised uncertainty about Propulsid's effectiveness

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