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Natrecor was FDA approved in 2001 for the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity. However, Natrecor side effects were being reported because the drug was being administered for uses it was not approved to treat, including severely ill congestive heart failure patients, especially in outpatient settings, as well as to replace diuretics, improve renal function and/or to enhance diuresis. There is an absence of clinical studies showing that these other Natrecor uses are safe and effective, and reports of severe side effects prompted medical experts and consumer advocates to push the drug’s manufacturer to conduct further large-scale, longitudinal studies of the drug.
Natrecor was supposed to be used only for hospitalized patients, but the treatment method was becoming increasingly popular in outpatient clinics nationwide. Patients were also being given the drug for much longer periods than it was originally approved for, which had grave Natrecor side effects. No study has been conducted to confirm if long-term use is safe or effective, and the off-label practice became controversial, as a result.
In several journal articles, Dr. Jonathan Sackner-Bernstein, a cardiologist at North Shore University Hospital in New York, provided data linking Natrecor to kidney problems and elevated death rates. According to Sackner-Bernstein, his patients had an 80% greater chance of fatal Natrecor side effects than patients who had received other treatments such as diuretics or vasodilators. The increased risks of mortality, unlike the kidney problems, were not realized until Natrecor had become widely used in outpatient clinics for extended periods of time. It was evident before and during the process of FDA approval that Natrecor side effects affecting the kidney were a risk, and it was noted in the drug’s labeling.
Scios, the drug’s manufacturer, argued Sackner-Bernstein’s observations regarding higher rates of fatal Natrecor side effects were because it included studies done at higher doses than are advised on the drug’s label, but patients were receiving these dose amounts. As many as 600,000 patients have been treated with Natrecor since its approval, and though prescribing drugs off-label is a common practice, Scios has been accused of using aggressive and questionable marketing strategies that led the drug to be used by an unnecessarily high number of people, thus exposing them to Natrecor side effects risks.
Dr. Eric Topol of the Cleveland Clinic has been highly critical of the way Scios is marketing Natrecor, even going so far to say it should not be on the market because the FDA was never given sufficient data upon which to have based its approval. Although Scios has since convened an independent expert panel of cardiologists, and taken the panel’s suggestions by launching a comprehensive recommended use initiative, serious and potentially deadly Natrecor side effects have already been suffered. In July 2005, the company 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.
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