Natrecor (generic name: nesiritude), was approved by the Food and Drug Administration (FDA) in 2001, and is used for a severe form of heart disease called decompensated heart failure, for which there are few available treatments. Many patients are treated instead with diuretics and vasodilators.

A new study is putting manufacturer Johnson & Johnson on the defensive over Natrecor. In a study that appeared in the April 20, 2005 issue of the Journal of the American Medical Association , a team of researchers asserted that Natrecor users suffered from a higher death rate than cardiac patients on other drugs, such as diuretics and vasodilators, based on data from three past Natrecor clinical trials.

"In conclusion, nesiritide may be associated with an increased risk of death within the first month after its use for the treatment of decompensated heart failure when compared to noninotrope-based therapies," the researchers wrote. Some of the researchers involved in the JAMA study also published a similar study in the medical journal Circulation in late March, 2005. In that analysis, the researchers said that Natrecor could hasten renal failure in some patients.

The Natrecor study was conducted by researchers Dr. Jonathan Sackner-Bernstein, of the North Shore University Hospital in Manhasset, NY; Drs. Marcin Kowalski and Marshal Fox, of St. Luke's-Roosevelt Hospital Center in New York; and Dr. Keith Aaronson, of the University of Michigan.

An FDA review of Natrecor in 2001 says the company's data could not "rule out a 50% increased risk" of death among patients given Natrecor. Natrecor's label warns it can cause kidney problems in certain users. The drug is marketed by Scios Inc., a wholly owned unit of Johnson & Johnson.