The U.S. Food and Drug Administration (FDA) recently approved Aranesp (darbepoetin alfa) for treatment of anemia
associated with chronic renal failure
. Aranesp combats anemia by stimulating bone marrow to produce red blood cells. During clinical trials, over 1,500 patients who used the drug reached and maintained targeted hemoglobin levels.
Side effects of the drug include, but may not be limited to, abdominal or stomach pain, general infection
, 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.
In January 2005, FDA and Amgen notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Aranesp. This safety information alerts physicians to the adverse 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 achieve hemoglobin levels of greater than 12 grams per deciliter. An increased frequency of adverse patient outcomes, including increased mortality and thrombotic vascular events were reported in these studies. As indicated in the Aranesp prescribing information, the target hemoglobin level should not exceed 12 grams per deciliter in men or women.
- Anemia Drugs: Overview
- Balance Problems: Overview
- Diarrhea: Overview
- Heart Problems
- High Blood Pressure (hypertension): Overview
- Joints & Muscles: Overview
- Low Blood Pressure (hypotension): Overview
- Speech Disorders: Overview