Trasylol May Have Caused 1,000 Death Per Month
Unfortunately, we cannot depend upon the Food & Drug Administration (FDA) or the drug industry to keep us safe from dangerous drugs. In the case of Trasylol, a drug formerly used during surgery to control bleeding, both the FDA and Bayer, the manufacturer of the drug, knew or should have know that the drug posed a serious health risk for patients.
In September 2006, Dr. Dennis Mangano presented the results of a study on Trasylol to the FDA. In this study, Dr. Mangano found that Trasylol increased the risk of kidney failure requiring dialysis. His study, published in the Journal of the American Medical Association, also found that Trasylol increased the risk of death by about 50 percent for some patients. Bayer executives attended Mangano’s presentation in order to defend Trasylol. Based on criticisms of the study, the FDA permitted Trasylol to remain on the market.
Bayer hired Harvard professor Dr. Alexander Walker to conduct its own study of the effects of Trasylol. Dr. Walker examined a database of nearly 70,000 hospital patients treated with the drug from January 1, 2003 to March 31, 2006. His results? Much the same as Mangano’s study: After adjusting for other factors, the researcher found the risk of death after surgery was 64 percent higher in the Trasylol group than in those taking a comparison drug. Further, he found that the drug also could increase the likelihood of congestive heart failure and strokes.
The real fraud here? Bayer had the reports of the Walker study, which was funded by Bayer, when it appeared before the FDA committee to attack the Mangano study! When asked why it did not tell the committee about the report, Bayer claims that this omission was an oversight, as the company’s management was not informed of the report until after the safety review.
Following the September 2006 meeting, the FDA did update the Trasylol label to include a “black box” warning, the agency’s strictest safety notice, stating that the drug placed patients at a high risk of kidney failure and death. The black box warning also cautioned that the use of Trasylol should be reserved only for patients who were at risk for significant blood loss during bypass surgeries.
With all of this information, why was this drug still on the market until November 2007? More on Trasylol and these deaths in the next blog.#