Natrecor / Nesiritide

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Modified on 2009/10/14 21:43 by admin
Natrecor, also known as nesiritide, is indicated for the treatment of patients suffering from acute congestive heart failure, especially those who are short of breath while at rest or with minimal activity. Natrecor works by mimicking the effects of a human hormone that dilates veins and arteries. The drug was approved by the U.S. Food and Drug Administration (FDA) in 2001 and is manufactured by Scios, Inc., a division of Johnson & Johnson.

Health officials began investigating Natrecor in May 2005 after the New York Times published an article describing how tens of thousands of patients were undergoing "tune-ups" by receiving infusions weekly over a period of several months at outpatient clinics. While legal, the FDA has not approved Natrecor for this off-label use. Cardiologists soon began speaking out against the drug's frequent use, pointing to the lack of clinical trials that support outpatient infusions and, more importantly, to Natrecor's link to kidney problems and death. Alternative medications, such as nitroglycerin, can be used just as effectively against heart failure, say the doctors.

Critics argue that Johnson & Johnson heavily promotes the medication, especially for off-label use, because of its lucrative sales. Figures for 2005 top $700 million, almost double 2004's numbers. Unfortunately, say many opponents of the drug, it is within federal guidelines for a pharmaceutical company to send information to a physician about a drug's off-label uses, as long as it is deemed for educational purposes only.

Opponents of Natrecor's use in outpatient clinics received promising news in July 2005 when Scios sent a letter to physicians detailing how an expert panel found that more clinical trials need to be conducted to help answer the concerns raised by cardiologists across the country. The panel also recommended that Natrecor only be used in the hospital and not in an outpatient center. Scios announced that it would be instituting an educational program for physicians on the proper uses of Natrecor.

See Also

  1. Heart Failure Drugs: Overview
  2. Kidney Failure
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