New FDA Approved Drug NATRECOR For Heart Failure Patients

by Medindia Content Team on  August 18, 2001 at 12:37 PM Drug News
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New FDA Approved Drug NATRECOR For Heart Failure Patients
The US government has approved a genetically engineered drug called NATRECOR to ease the breathing of hospitalized congestive heart failure patients.

Congestive heart failure is a condition in which the heart can't pump enough blood to meet the needs of the body's other organs. Most of the patients with congestive heart failure suffer flare-ups in which they gasp for breath and need hospitalization.

The U.S. Food and Drug Administration approved an injection of Natrecor as a way to treat these acute flare-ups. Natrecor, known chemically as nesiritide, is a biologically engineered version of a natural hormone that helps dilate blood vessels. That dilation helps blood flow from the weakened heart. But it also can cause seriously low blood pressure.

Two years ago, the FDA rejected approval of Natrecor because it caused so many cases of hypotension rates of 8 percent to 14 percent, depending on the dose used. Hence studies were conducted in another study group of 498 patients with a much smaller dose. This time, low blood pressure struck only about 4 percent of patients. So the FDA approved an injection containing the lower Natrecor dose.

Studies showed patients could breathe better as blood circulation and lung congestion improved with Natrecor treatment. California-based Scios Pharmaceuticals said it will start shipping Natrecor to hospitals this week and each vial, a day's treatment, will cost $380.


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