Bayer Withheld Important Safety Information from the FDA about Trasylol® And an Estimated 1000 Lives A Month were Lost Over 22 Months Until the FDA Finally Took Action

Trasylol® (Aprotinin injection) is an amino acid that Bayer manufacturers, deriving it from the lung tissue of cows. In many instances doctors inject Trasylol to reduce blood loss and to lessen the need for blood transfusions during coronary artery bypass graft surgery (CABG). Over the years, Trasylol® has garnered much controversy, including whether it was much more expensive to use that two alternative substances, whether it might cause renal complications and more recently, whether Trasylol® might place patients undergoing GABG at a higher risk of fatal anaphylactic reactions, especially patients with prior exposure to Trasylol® within 12 months.

Note that as recently as January 2008; Bayer still seems to be in denial about additional high risks of Heart failure, kidney dysfunction and death.  This 60 MINUTES video provides a concise report of issues surrounding Trasylol®.

Here is a timeline of events that might clarify this controversy. On November 5, 2007, after consulting with world health authorities, including the FDA Health Canada and German Federal Institute for Drugs and Medical Devices, Bayer announced that it would temporarily suspend worldwide Trasylol® marketing until the final results from the Canadian BART trial became available.

However, investigators had to suspend the BART trial in mid October 2007 because of safety concerns about the product.

The FDA’s interest heightened in 2006 when two published research studies revealed that patients who received Trasylol® during CBAG were at higher risk for damage to vital organs or possible death. It was January when the FDA began a serious investigation about safety and Trasylol® use.

After the January investigation ended in September, the FDA held an Advisory Committee meeting on Trasylol® safety on September 21, 2006. Not having any further studies in hand, the FDA recommended that physicians who use Trasylol® should carefully monitor patients for toxicity, particularly to the kidneys, heart or brain, and promptly report any adverse event information to Bayer and to the FDA. However, the FDA did not suggest that Bayer suspend Trasylol® sales.

About 6 days later, on September 27, 2006, Bayer told the FDA that it had conducted an additional retrospective safety study of Trasylol®, involving an analysis of the records of tens of thousands of patients who had received Trasylol®). The results of that Bayer funded study were essentially the same as those that Dr. Mangano had produced early in 2006.

Bayer may not have revealed its retrospective study to the FDA if the author of that study, Harvard investigator, Dr. Alexander Walker, had not “blown the whistle.” When he noticed that Bayer had not mentioned its study to the FDA during the September 21, 2006 meeting on Trasylol® safety, Dr. Walker promptly notified the FDA that there was such a study.

On November 23, 2006, a letter from Dr. Mangano appeared in the New England Journal of Medicine, indicating that he was troubled by the recent FDA announcement, which publically advocated the safety of Trasylol®. Dr. Mangano cited his recent 2006 study, and the FDA’s own initial 1993 warning regarding “kidney toxicity” as cause for concern. In addition, Dr. Mangano mentioned that the FDA had refused to consider using his 5,065-patient study, published in the New England Journal of Medicine, because of a minor disagreement regarding terms of use. However the parties did resolved the disagreement, but the FDA still refused to use Dr. Mangano’s data. Dr. Mangano ended his letter with the following statement:

“The FDA and its Advisory Committee should take a conservative, protective stance when independent evidence regarding drug safety presents itself. Instead, they appear to be protecting the drug rather than the patient.”

Somehow, documentary evidence seems to favor the veracity of Dr. Mangano’s statement.