Studies Link Trasylol To Kidney Problems, Heart Attacks, and Strokes

In mid-February 2006 the FDA issued a Public Health Advisory informing doctors and patients that the agency was evaluating the safety of Bayer AG’s heart surgery drug Trasylol (aprotinin injection) after new studies had linked it to higher risks of kidney problems, heart attacks, and strokes.  At the end of February, a "Dear Doctor" letter from Bayer regarding Trasylol was posted on Health Canada’s MedEffect web site.

Trasylol was approved by the FDA in 1993, and is typically used in patients who undergo coronary artery bypass graft (CABG) surgery to prevent blood loss during their surgery.

In January 2006 two medical journal articles were published which raised concerns about the safety of Trasylol.  The New England Journal of Medicine (NEJM) published an article which reported that Trasylol increased the risk of kidney failure and stroke by 100 percent, i.e., doubled the risk, and increased the chance of heart failure or heart attack by 55 percent.  In January 2006, also, the medical journal Transfusion published a second study report which suggested that Trasylol administration increased the risk for renal dysfunction or kidney failure, but those researchers did not find an increased rate of heart attacks nor strokes.

The FDA said it will hold an advisory committee meeting later in 2006 to investigate the benefits and risks of Trasylol as well as to determine if more safety measures are needed.  According to a statement issued by Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research:

We’re working to evaluate the potential risks and determine whether there is a need for further action.  In the meantime, we advise providers to carefully assess the benefits and risks of [Trasylol] for their patients.

In response to this news, a spokesman for Bayer said the drug company will cooperate with the FDA. At the same time, however, Bayer asserted that the study results set forth in the NEJM and Transfusion articles were "not consistent with the more than 15 years of clinical data and experience Bayer has amassed on [Trasylol]."  In addition, Bayer pointed out that both studies were observational studies, and as such have certain methodological limitations which prevent a direct assessment of whether Trasylol actually increased the risk for kidney problems, heart attacks, and strokes.

(Posted by: Tom Lamb)