Heart failure drug maker relays new deathsJan 3, 2006 | AP
The manufacturer of the heart failure drug Natrecor reported two additional deaths in patients involved in a study carried out three years ago but said it was confident the cases don't mean an increased risk.
The deaths had not been previously reported to Natrecor's manufacturer, Scios Inc., a Johnson & Johnson subsidiary, company spokesman Mark Wolfe said Tuesday.
The two cases bring to seven the number of patients who died within 30 days of treatment with Natrecor, also known as nesiritide. One patient treated with placebos, or dummy pills, died during that time.
Dr. Jonathan Sackner-Bernstein, a New York cardiologist and lead author of an April 2005 report published in the Journal of the American Medical Association that was critical of Natrecor, said the drug should be withdrawn.
"What it says to me is the information we published, if anything, understates the risks associated with the drug," Sackner-Bernstein said.
The cases are contained in an interim report being submitted to the Food and Drug Administration. The final version of the report, slated for completion by April 1, will measure how patients treated with Natrecor fared compared with those given placebos in the 30 days after treatment began.
The authors of a report on the original study, published in October 2005 in the Journal of Emergency Medicine, will submit an update that includes the two additional deaths, Scios said in a statement. The October report found no statistically significant difference in the outcomes of patients treated with Natrecor or a placebo.
Natrecor was approved in 2001 to treat serious breathing problems that often accompany heart failure.
Early last year, the FDA ordered that more information about the risk of death from Natrecor be added to the package insert for doctors, but the agency said it still believes the drug is a useful treatment.
The warning label on nesiritide already mentioned the potential for low blood pressure, kidney problems and more deaths than are seen with nitroglycerin.
Natrecor sales had declined significantly, Johnson & Johnson said in October, blaming media reports that the drug was being used too much on outpatients.
The intravenous drug has been given to more than 600,000 patients nationwide.