September 26, 2008 &8212; Use of high-dose epoetin alfa (Epogen, Amgen, Inc; Procrit, Ortho Biotech) in acute ischemic stroke patients has been linked to an increased risk for death, the US Food and Drug Administration (FDA) warned healthcare professionals today.
The warning was based on preliminary data from a German functional-ability study that employed doses of epoetin alfa (marketed as Eprex) that were considerably higher than those recommended by the FDA for the treatment of anemia, according to an alert issued by MedWatch, the FDA's safety information and adverse-event reporting program.
For the study, 522 adult patients with MRI-confirmed ischemic stroke were randomized to receive either placebo or 40,000 units of epoetin alfa administered intravenously for 3 days. Recombinant tissue-type plasminogen activator (r-TPA) was also used when clinically indicated.
Although investigators sought to demonstrate therapeutic improvements in functional ability, results over the first 90 days showed higher mortality in patients taking epoetin alfa than in those taking placebo (16% vs 9%), with roughly 50% of deaths occurring during the first week of treatment. Approximately 4% of epoetin-treated patients died from intracranial hemorrhage, compared with 1% of those receiving placebo.
According to an early communication, further information concerning this matter should be available from the FDA within the next several weeks. In the interim, close monitoring of adverse events in other clinical trials is advised to ensure that the potential benefits of therapy outweigh the risks to enrollees.
Epoetin alfa is an erythropoiesis-stimulating agent (ESA) approved by the FDA for the treatment of anemia in chronic renal failure patients, zidovudine-treated HIV-infected patients, cancer patients on chemotherapy; and to reduce the need for allogenic blood transfusions in surgical patients.
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