CHICAGO — 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 traditional medication such as nitroglycerin, or dummy pills.
The intravenous drug has been given to more than 600,000 patients nationwide.
"The public should be very alarmed," said Dr. Jonathan D. Sackner-Bernstein, a cardiologist at North Shore University Hospital in Manhasset, N.Y., and lead author of the study, which appears in today's Journal of the American Medical Assn. He said a large, rigorous study was needed to answer safety questions.
Johnson & Johnson spokesman Mark Wolfe called the analysis inconclusive and said nesiritide was safe and highly effective. Nesiritide, sold as Natrecor, is made by Scios Inc., a Johnson & Johnson subsidiary.
Dr. Robert Temple, director of the Food and Drug Administration's drug evaluation office, said there was "not a convincing case for increased mortality, but we will be looking at all available data."
The researchers acknowledged that the studies were small and not designed to examine increased death risks, so it was possible the results were just a chance finding.
They said they considered the possibility that nesiritide simply prolonged the lives of patients who would have otherwise died earlier, and they did not believe that explained their findings.
The analysis follows a study last month linking nesiritide to an increased risk of kidney problems. Scios announced last week it was convening a panel of outside experts to review those concerns. The FDA saw much of the data on higher death rates before it approved the drug. The warning label on nesiritide mentions the potential for low blood pressure, kidney problems and more deaths than are seen with nitroglycerin.
In the pooled analysis, 35 of 485 nesiritide patients, or 7.2%, died within 30 days of treatment, compared with 15 of 377 patients, or 4%, given other drugs. That 80% increased risk of death is higher than found in previous studies and would translate into thousands of deaths nationwide, Sackner-Bernstein said.
Sackner-Bernstein has done consulting work for GlaxoSmithKline, which owns the rights to market nesiritide in Europe.