Johnson & Johnson will also have to update the safety information on its erythropoiesis-stimulating agent (ESA) drug Procrit. ESAs are approved to treat anemia in patients with chronic kidney failure, and in cancer patients with anemia caused by chemotherapy.
However, a series of recent studies have cast doubt on the safety of these medicines, prompting the FDA to demand the strongest type of warning for a prescription drug, a black box warning.
Updated information for patients in the revised label notes that “patients should be informed of the increased risks of mortality, serious cardiovascular events, thromboembolic events, and tumor progression when used in off-label dose regimens or populations,” according to the FDA.
Physicians are advised in the boxed warning to use the lowest dose of ESAs that will avoid the need for red blood cell transfusions, and not to exceed 12 g/dL.
“Patient safety is unquestionably our top priority. Amgen is committed to providing timely and appropriate communications to physicians and patients whenever we become aware of new safety information that could affect clinical practice,” said Roger Perlmutter, executive vice president of R&D at Amgen.
The FDA is planning to review the safety and efficacy of ESAs at an upcoming meeting.