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FDA Says Another Safety Review of Anemia Drugs in the Works

Jan 7, 2010 | Parker Waichman LLP

Anemia drugs Procrit, Epogen and Aranesp are slated to undergo another safety review, following the publication of a clinical trail that linked one of them to an increased risk of stroke.

According to The New York Times, that study, called “Treat” was published in October in the New England Journal of Medicine. The goal of Treat was to see if using Aranesp to increase the red blood cell levels of people with diabetes and kidney disease would prevent death and cardiovascular problems. No statistically significant difference was found in deaths and cardiovascular problems between the study’s Aranesp and placebo groups. However, those who took Aranesp had double the risk of stroke.

According to the Times, in a commentary published this week in the online version of the New England Journal of Medicine, FDA officials wrote that the results of Treat “raise major concerns” about the use of the drugs to treat the anemia caused by chronic kidney disease. They also said that the “pronounced difference” in the stroke rate seen in the study was “very troublesome.” The commentary noted that “optimal hemoglobin targets have never been established” for patients with chronic kidney disease.” The authors also said that “more frequent hemoglobin monitoring” and other dosing changes might “improve outcomes” for patients treated with the drugs.  They stated that the FDA anticipated convening an advisory panel meeting sometime in 2010 to re-evaluate the use of the drugs in patients with kidney disease and to consider new ways to control dosage.

Procrit, Epogen and Aranesp are known as erythropoiesis-stimulating agents (ESAs).  They are used to treat anemia in patients with chronic kidney disease, while Procrit and Aranesp are also approved to treat anemia in cancer patients undergoing chemotherapy.

The anticipated advisory panel meeting would mark the fourth time since 2007 that Procrit, Epogen and Aranesp have undergone an advisory panel review.  In addition to being linked to blood clots, ESAs have been associated with the promotion of tumor growth when they are used at high doses to increase hemoglobin levels higher than label recommendations. Safety labeling for the drugs has been changed several times to include information about their risks.

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