Bayer withheld information

In September 2006, Bayer Pharmaceuticals, manufacturer of Trasylol (aprotinin), was faulted by the FDA for not revealing during testimony the existence of a commissioned retrospective study of 67,000 patients, 30,000 of whom received Trasylol and the rest other anti-fibrinolytics. The study concluded Trasylol carried greater risks. The FDA was alerted to the study by one of the researchers involved.

Trasylol was approved in 1993 in the United States to reduce bleeding during open-heart surgery.

The sale and use of Trasylol, manufactured by Bayer, was halted in 2007 after two studies published in the New England Journal of Medicine in 2006 indicated the drug raises the risk of kidney damage and death.

One of the research studies, both of which were published in January 2006, linked the drug to renal toxicity, myocardial infarction and stroke, and the other suggested the drug might increase the possibility of kidney damage, although it didn’t include increased risk of heart attack or stroke. The reports triggered a safety review by the Food & Drug Administration (FDA), which on Feb. 8, 2006, issued a Public Health Advisory about the findings of the study.

There were subsequent investigations of Trasylol conducted by the FDA, which convened a Cardiovascular and Renal Drugs Advisory Committee on September 21, 2006. The committee reviewed findings from the two previously published studies, along with a Bayer worldwide safety review, and the FDA’s own post-marketing database, which compiles voluntary adverse effect reports submitted by individuals and health care providers through the MedWatch program.

As a result of the meeting, the FDA recommended labeling changes for the drug, carrying stronger warnings.

However, it was not until a week later that Bayer informed the FDA of the results of another safety study it had conducted, which indicated even more serious side effects of Trasylol, including death, congestive heart failure and strokes.

An investigation revealed that a Bayer researcher was hired six months prior to the  committee meeting to review a 67,000-patient database to compare Trasylol side effects with those of other anti-bleeding medications, revealing Trasylol’s more serious side effects as compared to the other medicines.

According to an Official Report on Traysol prepared for Bayer Corporation by Zuckerman Spaeder LLP, and independent investigator, in August 2006, Bayer did not disclose the findings and conclusions from the report before or during the Sept. 21 FDA advisory committee meeting because Bayer’s doctors had questions about the study’s quality and so considered disclosure of the results “scientifically premature.”

While there has been no real repercussion, either from the FDA or any other source, for Bayer’s withholding of this information, in an Bayer statement about Traysol study dated August 16, 2007, the company said the decision to withhold the information was “a serious error of judgment.” The company said it analyzed its drug safety and monitoring procedures as a result, and would work to strengthen its “already strong structures and rigorous processes.”