Amgen updates Aranesp and Epogen prescribing information

Human therapeutics developer Amgen has announced that it has had updated safety information for Aranesp (darbepoetin alfa) and Epogen (Epoetin alfa) approved.

The updated safety information includes a boxed warning in the prescribing information for the drugs, which are in the Erythropoiesis-stimulating Agents (ESAs) class.

“Patient safety is unquestionably our top priority. Amgen is committed to providing timely and appropriate communications to physicians and patients whenever we become aware of new safety information that could affect clinical practice,” said Dr Roger M Perlmutter, executive vice-president of research and development at Amgen.

The revised label highlights the associated risk of “mortality” and “serious cardiovascular events” as well as the increased risk of both thromboembolic events and tumour progression when the drugs are used in “off-label dose regimens or populations”.

Information for the warning came from a number of studies, the results of which had previously been made known to the medical community.

In patients with active malignant disease that were not receiving a course of chemotherapy nor radiation therapy, ESAs were found to increase the risk of death when administered to a target haemoglobin of 12g/dl.

Amgen’s new European Development Centre in Uxbridge, London which will focus on research and development, was opened at the beginning of the month by prime minister Tony Blair.