FDA MedWatch - Aranesp (darbepoetin alfa) - Warnings revised to include reports of i

[Brian, ASN, RN]

FDA MedWatch - Aranesp (darbepoetin alfa) - Warnings revised to i nclude reports of increased mortality and thrombotic vascular events

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Amgen notified healthcare professionals of revisions to the WARNINGS

and PRECAUTIONS sections of the prescribing information for Aranesp,

indicated for the treatment of chemotherapy-induced anemia in patients with

nonmyeloid malignancies. 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.

Read the MedWatch 2005 MedWatch safety summary, including a link to the Dear

Healthcare Professional Letter and revised labeling at:

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#aranesp

[wmarat, BSN, RN]

FDA MedWatch - Aranesp (darbepoetin alfa) - Warnings revised to i nclude reports of increased mortality and thrombotic vascular events

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Amgen notified healthcare professionals of revisions to the WARNINGS

and PRECAUTIONS sections of the prescribing information for Aranesp,

indicated for the treatment of chemotherapy-induced anemia in patients with

nonmyeloid malignancies. 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.

Read the MedWatch 2005 MedWatch safety summary, including a link to the Dear

Healthcare Professional Letter and revised labeling at:

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#aranesp

Aranesp is also widely used in the cases of ESKD induced anemia.