Use of the drug Trasylol, or aprotinin, during heart surgery has been associated with an increased risk of kidney failure, heart attack, stroke and resulting death, according to studies.
One study reported in February 2007 found that Trasylol, used to reduce internal bleeding during surgery, was associated with a 48 percent increase in deaths within five years of bypass surgery. The observational study by researchers in California included 3,876 patients who underwent coronary bypass surgery.
On Nov. 5, 2007, the U.S. Food and Drug Administration announced that manufacturer Bayer Pharmaceuticals was suspending Trasylol from the market.
A report by the CBS news show 60 Minutes aired in February 2008 quoted a researcher who estimated that 22,000 patients -- or some 1,000 every month -- could have been saved if the FDA had removed Trasylol when his initial study showed a link between the drug and increased death rates two years earlier. (Full 60 Minutes report.)
If you or someone you known suffered a severe illness such as renal failure, heart failure, stroke or death after being administered Trasylol, or aprotinin, you may want to contact a Trasylol lawyer or an aprotinin lawyer.
A study published in January 2006 in The New England Journal of Medicine noted double the risk of renal failure among patients given Trasylol, which was approved by the FDA in 1993. That study also found a 55 percent increase in heart attacks and heart failures and nearly double the incidence of stroke or encephalopathy among patients given Trasylol.
The study was conducted by the non-profit Ischemia Research and Education Foundation in San Bruno , Calif. It concluded: “The association between aprotinin and serious end-organ damage indicates that continued use is not prudent.”
Bayer continued to maintain that Trasylol is “safe and effective treatment” and disputed the study as inconsistent with the company’s own clinical data and experience with the drug.
The study included 4,374 patients who were given aprotinin, a placebo and two other drugs used to control bleeding, aminocaproic acid and tranexamic acid, both generic drugs. The other drugs did not exhibit the same problems and were deemed by the study as safer and far less expensive.
In an editorial that accompanied the study report, Dr. Gus J. Vlahakes of the Harvard Medical School and the acclaimed Massachusetts General Hospital wrote: “Some surgeons and anesthesiologists who use the drug have been concerned about its potential risks since it was first approved for clinical use; yet until the recent report … sufficient data have not been available for an analysis of the risks and benefits of aprotinin.”
Kline & Specter,PC, with more than 40 attorneys, several of whom are also highly regarded doctors, has broad expertise and experience in pursuing pharmaceutical injury claims. Our law firm, based in Philadelphia and serving the Pennsylvania-New Jersey-Delaware region as well as clients nationwide, has produced superb results in a large number of personal injury cases. Contact a Trasylol lawyer - aprotinin lawyer today.
- On a 60 Minutes report, a researcher estimated that 22,000 patients could have been saved -- or about 1,000 per month -- if the FDA had removed Trasylol earlier. (Full story)
- Excess 30-day mortality in the Trasylol (aprotinin) arm of an ongoing heart surgery trial discovered by an interim safety analysis has forced researchers to shut down the aprotinin arm of the trial.
- Trasylol, used to control internal bleeding in heart surgery patients, increases the risk of kidney failure, according to a study reported in the New England Journal of Medicine.(Full story)