Contributed by Lisa Olen| 15 January, 2005 04:09 GMT
Patients who received higher-than-recommended dosages of two drugs similar to Aranesp experienced increased risk of TVEs and death.
Amgen (Nasdaq: AMGN) has revised the prescription labeling for its anemia drug Aranesp, warning that higher than recommended dosages could cause blood clotting and even death.Two recent studies involved similiar products that were given in high dosages for "off label" treatment strategies. An increased frequency of adverse patient outcomes, including thrombotic vascular events (TVEs) and mortality, were reported in those studies.
Study Participants Given High Dosages
Aranesp (darbepoetin alfa) is indicated for the treatment of chemotherapy-induced anemia in cancer patients. The target hemoglobin level should not exceed 12 grams per deciliter in men or women.
The products involved in the studies that spurred the Aranesp warning were Eprex (epoetin alfa) and NeoRecormon (epoetin beta). Patients with cancer were treated to attain higher hemoglobin target levels than required for the correction of anemia.
Additional details of the studies are included in the following sections of the revised Aranesp prescribing information: "WARNINGS -- Thrombotic Events and Increased Mortality"; and "PRECAUTIONS -- Tumor Growth Factor Potential."
No Change in Dosage Recommendations
Although the studies, which were conducted outside the U.S., did not involve Aranesp, Amgen incorporated the warning information into the Aranesp label because the drugs belong to the same class (erythropoietic agents).
This new information does not change the "Dosage and Administration" section of the Aranesp prescribing information, says Amgen. The target hemoglobin level should not exceed 12 grams per deciliter in men or women. |
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