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Natrecor – Revised Warning LabelFDA demands label changes to warn patients of side effects and risk of death from taking Natrecor (Nesiritide)In May 2005, the FDA ordered Johnson & Johnson’s subsidiary Scios, the manufacturer of Natrecor to include additional warning details for their popular heart failure treatment. Since its approval in 2001, reports have indicated several adverse side effects from Natrecor such as low blood pressure, kidney damage, and death. Natrecor is an intravenous medication that has been administered to over 600,000 U.S. patients with Congestive Heart Failure (CHF) and Acutely Decompensated Congestive Heart Failure (ADCHF). This drug acts as a “cardiac hormone” reducing shortness of breath by relaxing the muscles surrounding blood vessels and improving blood flow throughout the body. Many patients with heart failure find dyspnea or shortness of breath the most debilitating symptom of heart problems. Data from seven clinical studies indicates a significant risk of death in patients taking Natrecor for at least thirty (30) days. Some studies suggest this risk peaks at 30 days and then gradually decreases. The studies also state that 35 of 485 patients, or 7.2 percent, died within 30 days of Natrecor treatment, compared to 15 of 377 patients, or 4 percent, who died from other drugs. Medical experts and analysts suggest that these higher results from Natrecor may translate into thousands of deaths nationwide. For now, the FDA has decided to warn patients and physicians about the drug but not remove it from the market. The drug’s new package insert named "Effect on Mortality" makes mention of the clinical studies and the risk of death. A study published April 20, 2005, in 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 placebo. And in March 2005, an article in the journal “Circulation” found that Natrecor worsened kidney function by as much as 50 percent, based on a review of 1,200 patients. With reports of kidney problems and death in the clinical environment, heart doctors at the prestigious Cleveland Clinic voted unanimously to reduce or eliminate the use of Natrecor. Previously, the Cleveland Clinic was instrumental in the FDA’s decision to remove Bextra from the market, the popular NSAID with dangerous cardiac side effects. Each year, 250,000 people in the U.S. die from complications related to congestive heart failure. These deaths may or may not be related to medicine usage yet Natrecor remains on the market and its estimated annual sales will exceed $600 million this year as a result of aggressive marketing efforts. Natrecor In the News The intravenous heart failure drug Natrecor was approved in 2001, but researchers recently discovered patients were more likely to die in the first month of treatment compared to those who were administered a placebo. (Apr-20-05) [WASHINGTON POST]LEGAL NOTICE AND
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