Greg Monforton and Partners provides the latest news on the Trasylol side effects and related litigation.

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Bayer Suspends 2 Over Trasylol Data
Houston Chronicle | October 13, 2006

Bayer AG said Friday it suspended two employees involved in the decision to withhold data from federal health officials showing the company's drug Trasylol can cause deadly side effects.

Bayer, headquartered in Germany, is investigating why a study showing that Trasylol can increase the risk of death, kidney damage, heart failure and stroke was not disclosed at a Sept. 21 meeting with the Food and Drug Administration (FDA) to assess the safety of the drug. The company did not make the study public until more than a week after the meeting.

FDA Public Health Advisory
FDA | September 29, 2006

Since January, 2006, FDA has been conducting a safety review of Trasylol (aprotinin injection). The review was triggered by the results of two published research studies: one that reported an increase in the chance of kidney failure, heart attack and stroke in patients treated with Trasylol compared to those treated with other similar drugs, and the other that reported an increase in kidney dysfunction compared to another drug.

On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database.

FDA Public Health Advisory
FDA | February 8, 2006

On January 26, 2006, The New England Journal of Medicine (NEJM) published an article by Mangano et al. reporting an association of Trasylol (aprotinin injection) with serious renal toxicity and ischemic events (myocardial infarction and stroke) in patients undergoing coronary artery bypass grafting surgery (CABG). Another publication (Transfusion, on-line edition, January 20, 2006, Karkouti, et al.) suggests an association between aprotinin administration and renal toxicity among patients undergoing cardiac surgery with cardiopulmonary bypass. FDA is evaluating these studies, along with other studies in the literature and reports submitted to the FDA through the MedWatch program, to determine if labeling changes or other actions are warranted.

Trasylol Doubles Risk of Kidney Failure, Says Study
FDA News | January 27, 2006

Bayer Pharmaceutical's blood-loss treatment Trasylol doubles a patient's risk of kidney failure and increases risks of heart attack, heart failure and stroke, says a study published recently in The New England Journal of Medicine (NEJM).

Trasylol (aprotinin), which has been on the market for 13 years, has been given to an estimated one million surgery patients to limit bleeding, according to the Ischemia Research and Education Foundation (IREF), whose study in association with the McSPI Research Group was the basis of the NEJM article, "The Risk of Aprotinin in Cardiac Surgery."

Greg Monforton and Partners is investigating legal claims on behalf of those injured by Trasylol.

If you or a loved one has been injured by Trasylol, we invite you to contact us for a free, confidential consultation about your legal rights. We will represent clients throughout Canada in lawsuits against Bayer.

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Greg Monforton and Partners has grown to a highly respected products liability law firm with offices conveniently located throughout Windsor and Essex County, together with affiliate relationships with law firms throughout Ontario, Canada and the United States.

We are committed to protecting the rights of individuals injured by dangerous pharmaceuticals. The firm never represents insurance companies or product manufacturers. We only help people.