Trasylol Sales Suspended

It took nearly two years, but at the request of the Food and Drug Administration (the “FDA”) Bayer Pharmaceuticals Corp. (“Bayer”) has suspended sales of its anti-bleeding drug Trasylol. This is a victory for patients everywhere, but came too late for the estimated 22,000 patients whose lives may have been saved had Trasylol sales been suspended earlier (as estimated by a researcher on the CBS program "60 Minutes " aired on February 17, 2008).

Trayslol has been found to cause severe and sometimes life threatening damage to the heart, brain and kidneys. In January 2006, the New England Journal of Medicine published its findings on a study of 4374 heart bypass patients. 1,295 of the patients were administered Trasylol and the rest received a placebo. The study concluded that the patients who received Trasylol had significant, adverse health consequences, including the following: (1) A greater death rate than the other patients in the study who were not given Trasylol; (2) Double the risk of kidney (renal) failure requiring dialysis; (3) 48% increase in the risk of myocardial infarction (heart attack); (4) 109% increase in the risk of heart failure; (5) 181% increase in the risk of stroke .

The study also found evidence of multi-organ damage involving the heart, brain, and kidneys. Click on the following link to read a reprint of the New England Journal of Medicine Article on the risks associated with Trasylol: www.alawpro.com/files/risk_of_aprotinin.pdf.

The FDA responded to the New England Journal of Medicine's study by issuing a Public Health Advisory on Trasylol. The FDA stated that it was “[a]lerting doctors who perform heart bypass surgery, and their patients, that Trasylol, a drug used to prevent blood loss during surgery, has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks, and stroke in patients who undergo artery bypass graft surgery.” Click on the following link to read the Public Health Advisory Issued by the FDA: www.fda.gov/bbs/topics/news/2006/NEW01311.html.

On September 27, 2006 Bayer Pharmaceuticals told the FDA of the results of a new study, conducted by Bayer through a contract research organization, which appears to confirm the findings published in the New England Journal of Medicine. The study was based on the records of hospital data from 67,000 patients and was announced by the FDA in a Public Health Advisory the second of 2006, for the drug. On September 30, 2006, the New York Times published a piece in which it revealed that Bayer failed to disclose the outcome of its own study to the FDA in a timely manner. Bayer later admitted that it did fail to disclose the results of its study to the FDA. Click here to read Bayer's press release: www.trasylol.com/Trasylol_10_2_06.PDF.

Finally, on November 7, 2007 Bayer agreed to a marketing suspension of Trasylol, pending detailed review of preliminary results from a Canadian study that suggests an increased risk for death. According to the Wall Street Journal, Bayer said its decision came in the wake of requests or orders from regulators in the U.S., Canada, Germany and other countries.