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New Heart Drug Carries Risks

Nesiritide may increase patients' chance of dying after heart failure

Apr 20, 2005 | www.usnews.com

About 1 million people are hospitalized every year for acutely decompensated heart failure (heart failure in which symptoms get suddenly worse) and about 100,000 of these patients are given the relatively new drug nesiritide, sold by Scios Inc. as Natrecor, and usually given intravenously.

The drug was approved by the Food and Drug Administration in 2001 to treat shortness of breath that accompanies heart failure and was touted for its ability to improve patients' condition within three hours. But researchers from Chicago, New York, and Ann Arbor, Mich., say the drug may harm patients more than it helps them.

What the researchers wanted to know: Is nesiritide safer than traditional therapies for heart failure?

What they did: The researchers reanalyzed data from three previous studies on the drug. In all, they looked at the files from 862 patients, 485 of whom received nesiritide intravenously after an episode of heart failure. They looked at death rates for patients who were given nesiritide compared with patients who were given more-traditional medications such as diuretics, which help reduce the buildup of fluid in the body, and vasodilators, which open up blood vessels.

What they found: The researchers found that nesiritide increased a person's chance of dying by 86 percent compared with traditional medications. Thirty-five of the 485 patients (7.2 percent) who received nesiritide died within 30 days, and 15 of 337 patients (4.0 percent) who did not receive the medication died within 30 days. Because of the increased risk of death, the researchers concluded that nesiritide "may not be an optimal choice" as the first medication given after acute heart failure. Instead, traditional medications should be used first—especially since they cost much less. The researchers did not rule out the possibility that nesiritide could be used if other medications did not work. A spokesman for the company that manufactures nesiritide said that internal data do not show any increase in death rates compared with traditional therapies, though a separate paper published several weeks ago suggested the drug might harm the kidneys. Scios says it is convening an independent safety panel to look into the questions raised by that study.

What it means to you: If you are a heart-failure patient, it might be a good idea to talk to your doctor about the risks and benefits of different treatments given during acute episodes. Given that kidney failure could be a major risk of nesiritide, it would also be a good idea to monitor the Scios website and the FDA's Center for Drug Evaluation and Research to keep up on any new safety studies.

Caveats: Because the researchers got their data from other studies, they didn't have full information on all of the patients, including exactly when they died or why. The authors say they regard this paper as a hypothesis and say that other studies should be done to confirm their results.


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