Medication safety labeling updates and new warnings, April 2008

FDA's Oncologic Drugs Advisory Committee (ODAC) recommended that the erythropoiesis-stimulating agents (ESAs) epoetin alfa (Epogen, Amgen; Procrit, Ortho Biotech) and darbepoetin alfa (Aranesp, Amgen) should continue to be used for the treatment of chemotherapy-induced anemia in patients with cancer; however, the committee recommended that ESAs should not be used in patients with metastatic breast cancer or head and neck cancer. ODAC also recommended that ESAs should not be used in patients with cancer who are receiving potentially curative treatment.

The labeling information for darunavir (Prezista, Tibotec) has been updated to include a new warning regarding hepatotoxicity. Clinical trials and postmarketing adverse event reports have indicated a possible association between darunavir, used to treat HIV infection in antiretroviral treatment-experienced adult patients, and hepatotoxicity. Healthcare professionals should conduct hepatic laboratory tests before and after initiation of therapy with darunavir.

Boehringer Ingelheim has informed FDA of a potentially increased risk of stroke among patients treated with tiotropium (Spiriva HandiHaler), which is indicated for the treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). In a pooled analysis of 29 placebo-controlled trials, the manufacturer observed an estimated stroke risk of 2 patients per 1,000 patients treated with tiotropium versus placebo over a 1-year period. FDA is reviewing postmarketing adverse event reports and has asked for additional information from the manufacturer.