Researchers challenged the safety of the heart-failure drug Natrecor for the second time in two months, reporting it could raise patients’ risk of dying within a month of treatment.
Given intravenously to about 10% of people who are hospitalized for heart failure, the drug dilates blood vessels, reduces stress on the heart and relieves such frightening symptoms as shortness of breath. Natrecor is made by Scios Inc., a subsidiary of Johnson & Johnson.
The study, published in today’s Journal of the American Medical Association, found that Natrecor, the trade name for nesiritide, raised the risk of death in the first month after treatment by 80% compared with other heart-failure drugs. The researchers based their conclusions on an analysis of three major studies of Natrecor involving 485 patients and 377 controls.
“The individual studies were not powerful enough to look at mortality. Only by doing this analysis does real risk emerge,” says researcher Keith Aaronson of the University of Michigan, who worked with doctors at North Shore University Hospital and St. Luke’s-Roosevelt Hospital Center in New York. Only a long-term study of the drug’s risks would resolve the safety questions his research raised, he says.
In the March Circulation, the same researchers reported a 40% to 50% increased risk of kidney problems with Natrecor.
“We take any question about the safety of Natrecor seriously,” says Mark Wolfe of Johnson & Johnson.
“At the same time, a review of Scios’ full data set does not show a statistically significant difference in (death rates) between patients treated with Natrecor and those treated with traditional heart-failure therapies.”
On April 12, Scios announced it would convene an external panel of heart experts to evaluate the drug’s safety. Wolfe says the company would not comment further, and his statement did not address whether Scios would carry out the kind of study that Aaronson has proposed.
“When a question like this is raised, it has to be addressed,” says Rose Marie Robertson, the American Heart Association’s chief science officer.
Robertson says the critics’ study is hampered by its reliance on information from studies that involved different patient populations and different drug dosages. She says only a study designed to weigh the drug’s risks can resolve safety questions.
The heart association receives funding from Scios to inform doctors and the public about heart-failure treatments and would incorporate new information into the organization’s programs, Robertson says.
A Food and Drug Administration review of Natrecor in 2001 says the company’s data could not “rule out a 50% increased risk” of death among patients given Natrecor. “We have not reviewed the JAMA article and cannot answer specific questions at this point,” the FDA’s Laura Alvey says.
Natrecor had nearly $400 million in sales last year, quadruple the total for 2001, when the drug was introduced, reports IMS Health, a firm that tracks drug sales.
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