About The Recall
Bayer AG announced it would stop selling Trasylol after a study linked the product to a 50 percent higher risk of death than competing drugs in patients undergoing heart surgery. However, Bayer did not commit to keeping the drug off the market permanently. The company said the medicine will be kept off the market worldwide for two months or more so results from the test can be examined.
Data from an analysis of 67,000 patients last year linked Trasylol to a higher risk of death, kidney failure, congestive heart failure and stroke. Despite these results, Bayer continues to tout Trasylol claiming the data available now ``continue to support a favorable risk-benefit profile for Trasylol.'' This was not the first study linking Trasylol to dangerous side effects and death. Two studies released in January 2006 revelaed the same findings as the most recent study. One of these studies was kept from the FDA.
Trasylol was first approved by the FDA in 1993 to prevent excessive bleeding during cardiac bypass surgery. The drug was supposed to prevent patients from needing blood transfusions. . Sales of the injectable drug in 2005 were ($333 million before falling 34 percent in 2006 after the 67,000-patient analysis raised new safety concerns.
The company was criticized by regulators and lawmakers for failing to provide that analysis to the FDA last year, before an agency advisory panel considered Trasylol's safety. The company attributed the omission to an error by two employees in Germany, who were later suspended.
Legal Help is Available
If your or a loved one was injured by Trasylol you may have valuable legal rights. Mark & Associates, P.C. is evaluating cases involving heart bypass patients who suffered kidney damage or other side effects after their surgery. Many bypass patients do not know who medication was used during their surgery. Even if you don't know if Trasylol was used during your surgery Mark & Associates, P.C. will evaluate your case for free.
Please complete a Case Evaluation submission form on this page or call 1-866-50-RIGHTS (1-866-507-4448) for a free consultiation.