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

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    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/2...05.htm#aranesp


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    Quote from brian
    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/2...05.htm#aranesp


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


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