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Aranesp

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On January 14, 2005 Amgen and the FDA sent letters to doctors advising them of a revision to the warning label for Aranesp.

The FDA approved Aranesp on September 17, 2001 . Recently, the U.S. Food and Drug Administration (FDA) approved Aranesp (darbepoetin alfa) for treatment of anemia associated with chronic renal failure. Aranesp fights anemia by stimulating bone marrow to create red blood cells. Over 1,500 patients, who used the drug, achieved and maintained targeted hemoglobin levels.

On January 14, 2005 Amgen and the FDA sent letters to doctors advising them of a revision to the warning label for Aranesp. Two new studies with other drugs in the same class of Aranesp, known as erythropoietic drugs, have shown that using the drugs at higher-than-recommended doses increases the risk of adverse effects including blood clots and death.

Aranesp Side effects - Aranesp Lawyer

Side effects of the drug include, but may not be limited to, abdominal or stomach pain, general infection, dizziness, hypotension, hypertension, diarrhea, headache, and muscle pain. More severe side effects include increased incidence of cardiac arrest, acute myocardial infarction, fluid overload, vascular thrombosis, convulsions, and difficulty speaking. Aranesp is given by injection.

FDA and Amgen informed healthcare specialist of amendments to the WARNINGS and PRECAUTIONS sections of the prescribing information for Aranesp in January 2005. This safety information alerts doctors to the harmful effects observed with other products in this class in association with off-label dosing strategies. Two recent investigational studies with other erythropoietic products permitted or required dosing to obtain hemoglobin levels of greater than 12 grams per deciliter. An increased occurrence of adverse patient outcomes, including increased mortality and thrombotic vascular events, were reported in these studies. As indicated in the Aranesp prescribing data, the target hemoglobin level should not surpass 12 grams per deciliter in men or women.