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FDA Issues Warning on Off-Label Aranesp, Procrit, Epogen

Cancer patients not undergoing chemotherapy may be harmed by erythropoiesis-stimulating agent

TUESDAY, Feb. 20 (HealthDay News) -- The U.S. Food and Drug Administration has updated the warning on Aranesp (darbepoetin alfa) after a large clinical trial found that the drug did not reduce transfusions and may have increased mortality in cancer patients treated for anemia who were not currently undergoing chemotherapy. The findings may also apply to other erythropoiesis-stimulating agents, such as Epogen (epoetin alfa) and Procrit (epoetin alfa), according to the federal agency.

In the trial, anemic cancer patients not currently undergoing chemotherapy were randomized to Aranesp or placebo. Aranesp did not lower the risk of transfusion and may have increased the risk of mortality compared with placebo (hazard ratio, 1.25). A previous study suggested that cancer patients on chemotherapy had a greater risk of thromboembolism when treated with erythropoiesis-stimulating drugs with a target hemoglobin of greater than 12 g/dL.

The FDA recommends that health care professionals discuss the risks and warning signs with patients; adhere to the recommendation that the target hemoglobin be no more than 12 g/L; measure hemoglobin twice a week for two to six weeks after dosage adjustment; and decrease the dose if hemoglobin increases more than 1 g/dL in a given two-week period.

Patients with chronic renal insufficiency, cancer, zidovudine-treated HIV, hypertension or cardiovascular disease may require additional monitoring.

Aranesp is manufactured by Amgen.

More Information - FDA
More Information - Letter to Healthcare Professionals

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