Friday, March 09, 2007

FDA black box warning on anemia drugs

The FDA issued an advisory today on erythropoiesis-stimulating agents (ESAs) which are "approved to treat anemia in patients with chronic kidney failure, and in cancer patients whose anemia is caused by chemotherapy." From the SCIENTIFICAMERICAN.COM article:

"Recent reports of studies with erythropoiesis-stimulating agents (ESAs) have shown a higher chance of serious and life-threatening side effects and greater number of deaths in patients treated with these agents," an FDA public health advisory said.

"Because all ESAs work the same way, the findings from these studies apply to all ESAs; the FDA is re-evaluating the safe use of this drug class," the advisory said.

The FDA will gather further input from a May meeting of a panel of outside experts. More changes to the drugs' labels could follow that meeting, FDA officials said.
Click here to read the entire article. CME Providers might want to review their enduring material lists!

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