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Natrecor Deaths

Natrecor is a drug to treat heart failure made by Scios, a unit of Johnson & Johnson. The use of the drug has come under fire from some in the cardiology community because of potential toxicity to the kidneys, and information was added to the drug's label noting an increased risk of deaths among Natrecor patients compared to those on other treatments. Natrecor was FDA approved in 2001, and at the time of approval issues relating to kidney safety were known, but increased risk of Natrecor deaths was not entirely realized until use of the drug had become more widespread.

Dr. Jonathan Sackner-Bernstein, a cardiologist at North Shore University Hospital in New York, co-wrote several journal articles providing data showing elevated Natrecor deaths and kidney problems. The data showed Sackner-Bernstein's patients taking Natrecor were 80% more likely to die within the next 30 days than patients who had received other treatments, and while Scios argued the paper included studies with higher doses than advised on the drug's label, patients were being exposed to those amounts when receiving the treatment outside of hospitals.

Experts, upon learning about higher rates of Natrecor deaths, were critical of the way Scios marketed the drug. Natrecor was only approved to treat hospitalized patients, yet as many as 600,000 patients have been treated with the drug since its approval. According to Dr. Eric Topol of the Cleveland Clinic, Natrecor should not even be on the market because the FDA was never given sufficient data to base its approval. It can be years before a drug's side effects are realized, so using a drug off-label, while it does have its advantages, can also be very dangerous.

Natrecor was not intended to be used for as long as it has been prescribed in outpatient clinics, where it has been administered up to two times a week for up to 12 weeks, a dangerous practice considering the lack of studies confirming whether long-term use is safe or effective. Because of the off-label use of the drug, serious adverse effects, including Natrecor deaths, were discovered. As a result, Johnson & Johnson convened an independent expert panel of cardiologists in May 2005 to address the safety concerns.

The panel recommended Natrecor be restricted to severely ill hospitalized patients, and most experts agreed a large-scale clinical trial was needed to determine adverse effects of Natrecor and better assess risks of increased Natrecor deaths observed. Strict limitations were recommended, including not even administering Natrecor outside of the hospital and only specifically in cases of an acute type of heart failure when the patient comes to the hospital. In August 2005, following the recommendations of the panel to "immediately undertake a proactive educational program to inform physicians regarding the conditions and circumstances in which [Natrecor] should and should not be used," Scios announced it was launching a comprehensive recommended use initiative for the drug. Natrecor has been a commercial success, but since a massive drug recall in September 2004 involving the blockbuster arthritis painkiller Vioxx, controversy continues to hit the drug industry, including the reports of Natrecor deaths and kidney problems. For more information on Natrecor deaths, please contact us.

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