FDA: New Warnings for Anemia Drugs
Posted on: Wednesday, 14 November 2007, 18:00 CST
Revised statements about potential risks of three anemia drugs to patients with cancer or chronic kidney failure have been approved, U.S. regulators said.
The labeling changes for the drugs Aranesp, Epogen and Procrit also include a statement that symptoms of anemia, fatigue and quality of life have not been shown to improve in patients with cancer who take the drugs, the Food and Drug Administration said in a news release.
Epogen, Procrit and Aranesp, which are erythropoiesis-stimulating agents, are approved to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in some cancer patients, the FDA said.
For patients with cancer, the new boxed warnings stress that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter.
For patients with chronic kidney failure, the new boxed warning states that ESAs should be used to maintain a hemoglobin level 10 grams per deciliter to 12 grams per deciliter.
Source: United Press International
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