A genetically engineered drug that was hailed as a breakthrough in the treatment of heart failure in 2001 might actually raise patients’ risk of dying soon after treatment, researchers say.
Pooling results from three studies, researchers found that hospitalized patients given nesiritide (Natrecor®, Scios, Johnson & Johnson) appeared more likely to die in the first month after treatment than those given traditional medication (e.g., nitroglycerin) or a placebo. Nesiritide, a laboratory version of a hormone that the heart produces to ease breathing, is designed to treat the breathing problems that often accompany heart failure.
The researchers acknowledged that the studies were small and not designed to examine increased death risks. It is possible that nesiritide might have prolonged the lives of patients who would have otherwise died earlier, and they do not believe that explains their findings. The analysis follows a recent study linking nesiritide to an increased risk of kidney problems.
The FDA was aware of the higher death rates before it approved the drug. The warning label already mentions the potential for low blood pressure, kidney problems, and more deaths than are seen with nitroglycerin. Some physicians believe that the data are insufficient to cause alarm.