Bayer Hid Study About Trasylol® Risks, FDA Says
WASHINGTON, DC — October 6, 2006 —The heart surgery drug Trasylol® may actually increase the risk of heart problems, strokes, kidney failures and death, according to a major study that the manufacturer initially failed to make available to the Food and Drug Administration (FDA). Bayer Pharmaceuticals finally released the study at the end of September, six days after an FDA panel had met to discuss Trasylol®’s side effects and eight months after the agency began a safety review of the medication.
“For Bayer not to mention that [the study] was under way, that it was being analyzed or that results were available is appalling and will do significant harm to their reputation for transparency,” said one member of the FDA advisory committee, Dr. John Teerlink (New York Times, September 30, 2006). An FDA official, who asked to remain anonymous, told the newspaper that the agency learned about the study only because of a tip provided by a researcher.
Trasylol® Study Results
Trasylol® is the brand name for aprotinin, a protein produced from the lung tissues of cows. Given by injection, Trasylol® stops or slows certain enzymes that normally promote bleeding. As a result, Trasylol® decreases bleeding and the need for blood transfusions during surgery. Aprotinin has been on the market for 13 years. It was first marketed as Trasylol® in 1999.
Bayer used a contract research organization to review the records of 67,000 patients who underwent coronary artery bypass graft surgery. Thirty thousand patients were treated with Trasylol® and 37,000 were treated with alternate products. The report suggested that patients receiving Trasylol® were at increased risk for death, kidney failure, congestive heart failure and stroke, according to the FDA.
A prior report confirmed the link between Trasylol® and kidney failure and showed that there were no harmful kidney side effects with tranexamic acid, another drug that can be used to stem bleeding (Transfusion 2006 Mar; 46(3): 327–38). In another study with over 4,000 participants, heart bypass surgery patients who were given Trasylol® doubled their risk of kidney failure requiring dialysis compared to patients who did not take medicines to reduce blood loss (N Engl J Med. 2006 Jan 26; 354(4): 353–65). In addition, their risk of heart attacks or heart failure increased by 55 percent.
The FDA issued a Public Health Advisory that summarizes all three studies, including the latest Bayer–sponsored report. It will continue to evaluate Trasylol® and recommends that doctors limit its use to those cases where the clinical benefit of reduced blood loss is “essential to medical management of the patient and outweighs [Trasylol®’s] potential risks.”
A Case Against Bayer
Brayton Purcell is now evaluating cases of Trasylol® or aprotinin users who have developed kidney failures, congestive heart failures, or strokes. If you or a family member developed these conditions while taking Trasylol® during heart bypass surgery, please contact us through this web site or call 1–866–809–5240 toll–free.