FDA to AML Patients: Liquid Leukine Linked to Fainting
The US Food and Drug Administration and Bayer Healthcare Pharmaceuticals are withdrawing liquid Leukine® (sargramostim) from US markets after receiving reports the new formula causes patients to faint.
Leukine® is prescribed to fight infection in adult acute myelogenous leukemia patients who’ve undergone induction chemotherapy and others experiencing bone marrow transplant graft failure.
The withdrawal specifically applies to formulations of liquid Leukine® containing edentate disodium (EDTA). Lyophilized Leukine®, which does not contain EDTA, is still approved for medical use.
The FDA is advising healthcare professionals to immediately stop the use of liquid Leukine® and return all unused vials to the manufacturer.
Bayer announced it is establishing a special program to assist oncologists and hematologists who require priority access to lyophilized Leukine® due to the liquid formula’s withdrawal. More information on the return process can be obtained by calling Bayer toll-free at 1-888-842-2937.
Source: FDA MedWatch
Related Links: bayeroncology.com; Google™ Finance; drugdigest.org; dailystrength.org
Related Podcast: Emerging Therapies in Myeloma Pt 1 and Pt 2 on Blood CancerCAST by the Leukemia and Lymphoma Society
Technorati Tags: adverse drug reactions; Berlex Laboratories; blood cancer; hematologic malignancy; immunotherapy; transplant rejection; pharmacology; syncope; Wayne, NJ; white blood cell/WBC count
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