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Natrecor

The U.S. Food and Drug Administration approved Natrecor in 2001 to treat congestive heart failure or acute decompensating heart failure in which patients experience shortness of breath and the heart fails to adequately pump blood to other organs in the body. By mimicking a hormone-like molecule that dilates vessels to prevent blood from gathering in the heart and lungs to allow the patient to breath, Natrecor was supposed to be used for the treatment of hospitalized patients with applicable heart conditions, but the drug was increasingly being used for off-label uses.

Up to 600,000 patients have been treated with Natrecor since its approval, but serious safety concerns have emerged, linking the drug to kidney problems and elevated death rates. It can take years before actual drug risks are realized, after a drug is being widely used, but issues of kidney safety were known prior to and during the FDA approval process. Natrecor labeling specifically noted the kidney risks in the labeling, but the drug's manufacturer - Scios who was bought by Johnson & Johnson in 2003 - has been accused of aggressively marketing the drug, which could have exposed a greater number of people to the drug's risks unnecessarily.

Prescribing a drug off-label has become a common and increasingly controversial practice among doctors. While there have been significant benefits to prescribing drugs for purposes it was not specifically approved for, it is illegal for a company to promote a drug for reasons besides what the FDA has recognized and approved. Scios' marketing strategies for Natrecor have been questioned in addition to promotional materials the company provided doctors.

Sales of Natrecor reached nearly $700 million in 2005, mostly because the drug is an expensive option, costing nearly 50 times more than standard therapy options. In the promotional materials Scios provided doctors it advised them on how to bill Medicare for Natrecor uses not approved by the FDA. Several journal articles provided data linking Natrecor to kidney problems and elevated death rates, but Scios argued one of the papers by Dr. Jonathan Sackner-Bernstein, a cardiologist at North Shore University Hospital in New York, included studies done at higher doses than are advised on Natrecor's label.

Sackner-Bernstein's patients taking Natrecor were 80 percent more likely to die within the next 30 days than patients who had received other treatments. In May 2005, J&J announced it would revise Natrecor labeling to include data indicating an increased risk of mortality within 30 days compared with patients taking a placebo or other treatment, in compliance with the FDA. Even with the increased Natrecor warnings, medical experts still wanted further studies to better determine Natrecor health risks.

An independent expert panel of cardiologists convened by J&J recommended, in May 2005, strict limitations on Natrecor and for the drug to be restricted to severely ill hospitalized patients. J&J also acknowledged in July 2005 that it had received a subpoena from the U.S. Attorney's office in Boston requesting documents related to the sales and marketing of Natrecor.

If you would like more information on Natrecor side effects, please contact us to confer with an attorney.

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