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Contact a Miami Natrecor Lawyer
Defective Drug Side Effects Topics
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Natrecor (nesiritide) is the first member of a new drug class called human B-type natiruretic peptide manufactured from E coli using recombinant DNA technology. FDA approved in 2001, Natrecor was intended “for the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity,” and the drug has enjoyed success. As many as 600,000 patients have been treated with Natrecor since its approval, but the drug, marketed by Johnson & Johnson’s Scios subsidiary, has become controversial and has been criticized from some in the cardiology community because of potential toxicity to the kidneys.
New information was also added to Natrecor’s label in May 2005, including data noting an increased risk of death in those taking the drug compared with those on other treatments. Scios said it was changing Natrecor’s labeling in compliance with the FDA, and the company also convened an independent expert panel of cardiologists to review and assess important data associated with the medicine. The panel, headed by the highly respected heart researcher, Harvard’s Dr. Eugene Braunwald, made recommendations on the ongoing and planned clinical development program for Natrecor, as well as recommendations for use.
Among the panel’s recommendations were strict limitations on Natrecor, including not using it for scheduled “tune-ups’ or administering it outside of the hospital. Natrecor was supposed to be used for the sole purpose of treating hospitalized patients with applicable heart conditions, however, the off-label use of Natrecor allowed the drug to be used in outpatient clinic and administered, at much greater doses. According to Dr. Eric Topol of the Cleveland Clinic in the July 14, 2005 edition of the New England Journal of Medicine, Natrecor should not even be on the market because the FDA was never given sufficient data upon which to have based its approval.
Topol was also highly critical of the way Scios was marketing Natrecor, and it has been asserted that that questionable marketing strategies were employed to allow the high number of Natrecor prescriptions despite the limited approval of the drug, as well as the company’s ability to reach almost $700 million in Natrecor sales in 2005. Although Scios argued the company could not control how doctors prescribe Natrecor, the company provided doctors with promotional materials advising them on how to bill Medicare for Natrecor uses clearly not approved by the FDA because of the high cost of the drug.
In July 2005, Johnson & Johnson acknowledged it had received a subpoena from the United States Attorney’s Office in Boston requesting documents related to the sales and marketing of Natrecor. Since the controversy surrounding Natrecor arose, the company has since added a clear disclaimer to its hotline used by doctors seeking information. In addition, Scios announced in August 2005 it was launching a comprehensive recommended use initiative for Natrecor based on the panel’s recommendations.
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