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Natrecor Kidney Problems

Natrecor, a heart drug made by Scios, a unit of Johnson & Johnson, was FDA approved in 2001. An article published in the New England Journal of Medicine suggested Natrecor might lead to kidney problems and possibly higher mortality rates. Natrecor kidney problems were known prior to and during the process of FDA approval, and while the drug's labeling carried warnings of the potential for side effects, they were inadequate, according to some critics.

In May 2005, J&J said it was complying with the FDA and revising Natrecor labeling to include data indicating an increased risk of mortality within 30 days for Natrecor patients compared with patients on a placebo or other treatments. While updated labeling was seen as a positive change, many experts did not believe those actions alone were adequate considering the potential for deadly effects and kidney problems.

The company convened an independent expert panel of cardiologists, and in May 2005, the panel recommend Natrecor be restricted to severely ill hospitalized patients. Patients were being exposed to higher risks of Natrecor kidney problems because of the growing widespread use of the drug for "off label" purposes. Doctors routinely prescribe drugs off-label, that is to treat things it was not specifically FDA approved to treat, and the practice, though it helped reveal there might be serious Natrecor side effects like kidney problems, is also controversial.

Natrecor was only intended to be used for treating hospitalized patients with congestive heart failure or acute decompensating heart failure. Off-label prescriptions are becoming more controversial in the wake of major drug recalls, and the increased risks of Natrecor kidney problems have highlighted some possibly questionable marketing strategies that could have exposed a greater number of people to the adverse effects unnecessarily. Even though doctors are allowed to prescribe off-label, a company can only promote a drug for conditions the FDA approved it to treat.

In the journal Dr. Eric Topol of the Cleveland Clinic was highly critical of the way Scios was marketing Natrecor, even saying it should not remain on the market. According to Topol, the FDA was never given sufficient data to base its approval on. Several marketing strategies Scios used have been questioned, including how the company provided doctors with promotional materials advising them on how to bill Medicare for Natrecor uses that are not approved by the FDA.

In another blow to Scios, reports in early September 2005 said an experimental drug from Protein Design Labs Inc. could relieve symptoms and cut mortality in patients with advanced heart failure without causing kidney toxicity. Being able to maintain kidney function is especially important in patients with decompensated congestive heart failure. Until Natrecor kidney problems emerged, the drug had been a commercial success, but newer drugs without the safety risks could compete with Scios and threaten some of its market share.

For more information on Natrecor kidney problems, please contact us to confer with an attorney.

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