FDA action related to medication safety and reliability, October 2007

Key Points

At a joint meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panel members recommended that marketing authorization for aprotinin injection (Trasylol, Bayer) should be continued. The committees convened to discuss the safety issues associated with aprotinin, including the risk of renal failure and dysfunction, death, heart attack, and stroke. Although the committees recommended that this agent should remain on the market, panel members also recommended that product labeling for aprotinin should be revised to emphasize the risks of off-label use of this drug. The committee members also suggested that Bayer should conduct additional clinical trials to assess the risks and benefits of this agent.

At a joint meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panel members recommended that labeling for erythropoiesis-stimulating agents (ESAs) should not be changed to state that the target hemoglobin level should not exceed 11 g/dL when ESAs are administered for the treatment of anemia in patients with chronic renal failure, whether or not patients are on dialysis.