Safety labeling updates & new warnings


A discussion of FDA-requested boxed warnings and medication labeling changes

FDA has requested that a boxed warning be added to the prescribing information for the erythropoiesis-stimulating agents (ESAs) darbepoetin alfa (Aranesp, Amgen) and epoetin alfa (Epogen, Amgen; Procrit, Ortho Biotech). The boxed warning provides information about using the lowest possible dose of the agent to avoid serious cardiovascular and arterial and venous thromboembolic events; cautions that ESAs increase the risk for death and serious cardiovascular events when they are dosed to achieve a target hemoglobin >12 g/dL; warns that the use of ESAs to achieve a target hemoglobin ≥12 g/dL shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy, shortened overall survival and increased deaths attributed to disease progression in patients with metastatic breast cancer receiving chemotherapy, and increased the risk of death in patients with active malignant disease not undergoing treatment with chemotherapy or radiation therapy; and cautions that patients treated pre-operatively with epoetin alfa to reduce allogenic red blood cell transfusions had a higher incidence of deep venous thrombosis. The updated labeling also includes additional warnings about increased mortality, cardiovascular events, tumor progression, and uncontrolled hypertension associated with ESA use.

FDA has requested that a boxed warning be added to the labeling for omalizumab (Xolair, Genentech). The new warning emphasizes that omalizumab (approved for the treatment of moderate-to-severe persistent asthma in adults and adolescents who have tested positive for a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled steroids) may cause anaphylaxis after any dose of the agent, even if there was no reaction to the first dose; anaphylaxis may be delayed up to 24 hours after the dose is administered. FDA has also requested that the manufacturer create a Patient Medication Guide to strengthen the existing warning for anaphylaxis.

FDA has requested that a boxed warning be added to the prescribing information for rituximab (Rituxan, Genentech). The new warning emphasizes that JC virus infection resulting in progressive multifocal leukoencephalopathy and death has been reported in patients with hematologic malignancies or systemic lupus erythematosus treated with rituximab.

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