CHICAGO, April 19 -- A genetically engineered drug that was hailed as a breakthrough in the treatment of heart failure when it was approved in 2001 might actually raise patients' risk of dying soon after treatment, researchers say.
Pooling results from three studies, the researchers found that hospitalized patients given nesiritide appeared much more likely to die in the first month after treatment than those given medication such as nitroglycerin or dummy pills.
The intravenous drug has been given to more than 600,000 patients nationwide.
Jonathan D. Sackner-Bernstein, a cardiologist at North Shore University Hospital in Manhasset, N.Y., and lead author of the study in Wednesday's Journal of the American Medical Association, said a large study is needed.
Johnson & Johnson spokesman Mark Wolfe called the analysis inconclusive and said nesiritide is safe and highly effective. Nesiritide, sold as Natrecor, is made by Scios Inc., a subsidiary. Robert Temple, director of the FDA's drug evaluation office, said there is "not a convincing case for increased mortality, but we will be looking at all available data."
