Trasylol-Kidney Failure And Death
Aprotinin, sold under the brand name Trasylol was approved by the Food and Drug Administration for use in 1993. Trasylol was used to control bleeding in hundreds of thousands of heart bypass patients. Bayer AG developed Trasylol to prevent blood loss and to limit the need for blood transfusions during bypass surgery.
Bayer AG marketed the drug aggressively and it became one of Bayer’s fastest growing medications with more than 150,000 heart patients being administered the drug each year. Bayer was forced to pull Trasylol from the market in 2007 after researchers linked it to serious side effects like kidney failure, heart attacks, and strokes.
Kidney Failure And Death
Two separate studies that were published in the February 2008 issue of the New England Journal of Medicine added sufficient proof that the drug is not safe. The first study followed over 10,000 patients who underwent bypass surgery and were administered the drug at Duke University Medical Center from 1996 through 2005.
The first study results showed that 6.4 percent of the patients who were administered Trasylol died within 30 days of the bypass surgery. The failure rate of the patients receiving Trasylol was nearly 2.5 times higher than those patients receiving a comparison drug or those patients that received no treatment for bleeding at all.
The second study was financed by Bayer AG and followed over 78,000 patients in the United States from 2003 to 2006. The second study results showed that the Trasylol group had a risk of death 64 percent higher than the group taking the comparison drug. Through continued studies of the drug Trasylol it was concluded that halting the drug’s use would prevent between 10,000 and 11,000 kidney failures per year and save consumers over $1 billion per year in dialysis costs.
Bayer AG finally suspended the marketing of Trasylol after a Canadian study showed preliminary results that linked Trasylol’s use to a higher incidence of kidney failure and death. There has been an increasing number of lawsuits filed by patients who experienced severe side effects after being administered Trasylol.
FDA Requests Suspension Of Trasylol
“F.D.A. could not identify a specific patient population where the benefits of using Trasylol could outweigh the risks,” said Dr. John Jenkins, director of the agency’s office of new drugs. “I would say that the F.D.A. decision to request a suspension was one we reached independent of German authorities or any other regulatory agency,” Dr. Jenkins said.
The Atlanta Journal Constitution, in an article about Trasylol at the time of the ongoing studies, reported Nader, the famous consumer advocate, as saying, “Killing 1,000 people a month and it was finally mentioned on national television.” Many consumers who have been administered Trasylol are not even aware of it because it was administered by injection during recovery after the surgery was completed.
Your doctor will be able to tell you what drugs you were given. If you or a loved one has suffered heart failure, kidney failure, or a stroke after coronary surgery, please contact a personal injury attorney at The Law Offices of Nadrich & Cohen, we can help you.