Bayer says some regulatory authorities issue caution on Trasylol use

By Lisa Kerner

Erie, Pa., Feb. 9 - Bayer HealthCare said it is working with global regulatory authorities to evaluate recent reports published in the medical literature concerning Trasylol (aprotinin injection), a broad-spectrum proteinase inhibitor, and communicating guidance to physicians and the public concerning these reports.

Articles were published in the New England Journal of Medicine and the journal Transfusion, according to a company news release.

These articles report an association of aprotinin/Trasylol with an increased risk of cardiovascular events (myocardial infarction or heart failure), cerebrovascular events such as stroke, encephalopathy or coma, and renal dysfunction or failure in patients undergoing coronary artery bypass graft (CABG) surgery.

Several health authorities have or may issue guidance to physicians and patients in their respective markets. Bayer is informing health care providers by mail and posting information outlining background information concerning this issue.

The FDA has posted an "Alert for Healthcare Professionals" and a "Public Health Advisory" concerning Trasylol on its web site along with questions and answers related to this issue.

According to the release, guidance from regulatory authorities suggests that while the evaluation continues, physicians should consider limiting Trasylol use to situations where the clinical benefit of reduced blood loss is essential for medical management of the patient and outweighs potential risks.

The studies noted in the NEJM and Transfusion were observational studies, according to the release, and as such have certain methodological limitations, such as imbalances in baseline characteristics of patients.

The NEJM publication studied patients undergoing CABG surgery who received either aprotinin or one of two other drugs intended to decrease perioperative bleeding. The authors reported an association of aprotinin with an increased risk of cardiovascular events (myocardial infarction or heart failure), cerebrovascular events such as stroke, encephalopathy or coma, and renal dysfunction or failure in these patients, the release stated.

The Transfusion study suggested that Trasylol administration increased the risk for renal dysfunction or failure. The Transfusion study authors did not find an increased rate of cardiovascular or cerebrovascular events in Trasylol-treated patients and reported comparable mortality rates between the control treatment group and the Trasylol group, the release said.

Bayer HealthCare, a subgroup of Bayer AG, is a health care and medical products company based in Leverkusen, Germany.

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