Contributed by Ron Gara| 10 June, 2005 15:08 GMT
Documents from lawsuits against Johnson & Johnson show the company did not conduct safety studies urged by consultants and federal regulators that could have revealed the drug's danger early on.
Newly obtained documents have revealed
Johnson & Johnson's heartburn drug Propulsid might have been responsible for serious heart problems in some patients.
The corporate and government documents tied the drug to dozens of deaths and heart troubles in more than 100 patients -- including infants, the New York Times reported Friday.
The documents showed federal officials told Johnson & Johnson in 1998 the drug might have to be banned from pediatric use, or withdrawn from the market completely. However, the parties instead agreed on new warnings for the drug's label.
Johnson & Johnson pulled Propulsid from the market in 2000 when a government hearing threatened to draw attention to the drug's history.
Did Not Conduct Safety Studies
Documents from lawsuits against Johnson & Johnson show the company did not conduct safety studies urged by consultants and federal regulators that could have revealed the drug's danger early on.
Additionally, the documents showed the
Food and Drug Administration did not disclose company research that cast doubt on Propulsid's effectiveness against digestive disorders it was being used to treat.
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