FDA Calls for the Recall of Trasylol in the Health Market

Looks as though, Bayer Pharmaceuticals Corp. will have to find a safer alternative for patient's undergoing cardiac surgery. The drug Trasylol or its generic name "Aprotinin" May pose more of a risk to patients, so the FDA is recalling for the suspension of it in the marketplace.

According to the FDA, Bayer Pharmaceuticals Corp. has agreed to stop the marketing of Trasylol. Based on a study performed by the Canada's Ottawa Health Research Institute trasylol poses a serious risk to a patient's safety.

Trasylol (Aprotinin) is generally used for prophylactic use to reduce preoperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.

"There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose." Some doctors will still have limited access to trasylol, which they may use if they identify cases where the benefits far outweigh risk of using it. The FDA expertly knows that there are not many treatment options for patients undergoing cardiac bypass surgery.

How will the health industry determine when the drug outweighs the risk of permitting its use? Still the FDA and Bayer Pharmaceuticals Corp. are working diligently to remove the trasylol from the marketplace. Will this cause a shortage of alternatives drugs from this purpose?

The Ottawa Health Research Institute reported to the FDA, "They stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study." "Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling."