FDA Orders Heart-Risk Info on DrugsApr 25, 2005 | AP
The Food and Drug Administration is ordering that more information about the risk of death from a heart failure drug be added to the package insert for doctors.
The expanded data on nesiritide, sold as Natrecor, includes findings from seven studies with pooled results suggesting the drug might increase patients' risk of death within 30 days of treatment. Four of the studies found an increased risk of death compared with other treatments, and three found a decreased risk.
The drug is given intravenously and has been used by more than 600,000 patients in the United States since it was approved in 2001 to treat serious breathing problems that often accompany heart failure.
The revision, required for the professional label doctors are supposed to read, also adds information on 180-day death rates, showing virtually no increased risk of death with Natrecor. The revision notes that the studies were small, with relatively few deaths.
The labeling information had already mentioned a potential for low blood pressure and kidney problems, along with data from one study showing more deaths with Natrecor than nitroglycerin.
The FDA listed the required changes in a letter sent Wednesday to Scios Inc., the Johnson & Johnson subsidiary that makes Natrecor.
Scios spokesman Doug Arbesfeld said Monday that the company had agreed to the new labeling. He said the studies listed in the revised data will be reviewed by a company panel examining the drug's safety.
A study in the April 20 Journal of the American Medical Association said hospitalized patients given Natrecor appeared more likely to die in the first month after treatment than those given traditional medication or dummy pills.
Dr. Robert Temple, director of FDA's drug evaluation office, said he was not convinced that Natrecor increases patients' risks of dying and that the FDA still believes it is a useful drug.