Natrecor prescription guidelines to be revised
Natrecor, the popular drug given to heart patients, continues to face criticism from experts. Now according to Scios (a division of Johnson & Johnson), an independent panel of experts says that Natrecor should be restricted and only used with acutely ill hospitalized patients. They want Johnson & Johnson to conduct a more comprehensive clinical trial, as available data indicates that Natrecor may increase the risk of kidney problems and death. (Related article: Natrecor increases risk of death)
Natrecor is the latest drug to raise safety concerns long after receiving Food & Drug Administration approval. Currently Viagra is another drug that is facing a recall possibility apart from other approved drugs that have come under a cloud about their safety after they were on the market for years. Vioxx and Bextra have been recalled while Celebrex received a black box warning. Other NSAIDs, and more specifically Ibuprofen and Diclofenac, have also been found to increase risks of heart attacks after being approved by the FDA and being available for years.
The panel, which was convened by Dr. Braunwald at the request of Scios, also provided guidance and counsel on the ongoing and planned clinical development program for the product as well as recommendations for use. The panel said Natrecor should not be used routinely for heart-failure patients even though there are few similar drugs, until more research is done. It is suprising to know that many doctors prescribe Natrecor without thinking much about it. Not too long ago, the Cleveland Clinic had almost recommended a complete ban on use of Natrecor but decided to only put restrictions on its prescription.
According to a written statement, J&J has accepted the panel's recommendations, and are planning a clinical study. The panel recommend that the drug should be reserved for hospitalized heart-failure patients who have trouble breathing at rest and not outpatients who have breathing problems after mild exertion. Scios noted that the panel recommended a use for NATRECOR that is slightly narrower than what is outlined in its approved label. The company is contacting regulatory agencies to discuss how to best address this recommendation. “The panel also described uses for which it believes NATRECOR is inappropriate,” said Dr. Darlene Horton. “Scios fully agrees that these are areas for which there are not sufficient data to support the use of NATRECOR. The company will continue and build upon its efforts to educate physicians regarding appropriate use.”
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