Procrit, Epogen and Aranesp Set for Another Safety Review

<"http://www.yourlawyer.com/topics/overview/procrit">Procrit, <"http://www.yourlawyer.com/topics/overview/epogen">Epogen and <"http://www.yourlawyer.com/topics/overview/aranesp">Aranesp will soon undergo another Food & Drug Administration (FDA) review to re-evaluate their use in people with chronic kidney disease. This would mark the fourth time since 2007 that Procrit, Epogen and Aranesp have undergone an advisory panel review.

Procrit, Epogen and Aranesp are known as erythropoiesis-stimulating agents (ESAs). ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. 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.

ESAs have long been the subject of safety concerns, and have had their safety labeling updated several times since 2007. 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.

According to The New York Times, The FDA’s decision to subject Procrit, Epogen and Aranesp to yet another advisory panel review was prompted by another study that suggested that high doses of one of the drugs might cause strokes. 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 said that they anticipated convening an advisory panel meeting sometime in 2010 to re-evaluate the use of ESAs in patients with kidney disease and to consider new ways to control dosage. The 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.

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