Healthcare giant, Johnson & Johnson, negotiated new warnings for its anti-ulcerant, Propulsid (cisapride), with the US Food and Drug Administration in order to keep the drug on the market, even though it had been linked to heart problems and even death, according to a report in the New York Times.
The newspaper claims that J&J ultimately pulled the plug on the drug in 2000 ahead of a governmental hearing that would have thrown the issue into the spotlight. Citing “newly obtained corporate and government documents” as well as documents from lawsuits, the New York Times notes that J&J did not conduct safety studies that would have highlighted the problems associated with the lucrative drug’s use. Neither did FDA officials disclose company research that questioned the product’s efficacy, it adds. Furthermore, the newspaper says its findings suggest that J&J helped fund programmes aimed at encouraging Propulsid’s use in children – in spite of never having been proved effective in this population.
Last year, J&J agreed to pay between $69.5 million and $90 million to settle claims that the anti-ulcerant caused heart problems [[06/02/04g]].