The advisory was based on two recently published observational studies. One reported that Trasylol may be associated with an increased risk of MI, stroke and renal dysfunction, and the other reported that Trasylol may increase the risk of renal toxicity. Neither study used the randomization or control procedures that would be needed to thoroughly evaluate the drug’s safety.

The FDA is evaluating the information from these studies, along with other safety information, to determine if additional action is necessary. In the meantime, here are FDA’s recommendations:

• Consider limiting Trasylol to those situations where reduced blood loss is essential to patient management and outweighs the potential risks.

• Carefully monitor Trasylol patients for toxicity, particularly to the kidneys, heart or central nervous system.

• Report adverse events to Bayer, the drug’s manufacturer, or through the FDA MedWatch program.