The drug Trasylol, or generic aprotinin, is an antifibrinolytic agent commonly given to heart surgery patients in order to control bleeding. Since its approval by the FDA and release by Bayer AG in 1993, Trasylol has been widely used in the U.S. However, in 2006, an independent study published in the New England Journal of Medicine revealed serious risks of life-threatening side effects associated with Trasylol use.
Results of the Study
Dr. Dennis T. Mangano of the Ischemia Research and Education Foundation led a study examining more than 4,300 heart surgery patients being treated for coronary artery blockages or other heart complications. Patients were divided into groups. Some received Trasylol, some were given alternative generic medications such as tranexamic acid or aminocaproic acid, and the remaining patients received no medication.
Side Effects of Trasylol
The patients who received Trasylol were shown to have a 50 percent increased risk of experiencing a heart attack. Heart attacks were caused by a lack of sufficient blood supply in the heart muscle, allegedly due to Trasylol use.
Additionally, patients receiving Trasylol displayed almost twice the risk for renal failure, a 181 percent increased risk of stroke, and a significantly increased risk of heart failure compared to patients taking the generic alternatives or no drugs. The total risk of death for patients taking Trasylol increased from 1.3 percent to 2.8 percent compared to the other patients.
Researchers propose that insufficient research during Trasylol's development resulted in a serious miscalculation of the drug's risks. However, Bayer AG, the makers of the drug, claims that the 2006 study is inconsistent with their own study on the drug, which included years of tests and observations. However, surgeons and doctors are gravely concerned over the results of the 2006 study. Researchers estimate that using alternative generic drugs instead of Trasylol would have:
- Averted 11,050 kidney complications.
- Saved $250 million in medication expenses for medication.
- Spared $1 billion in healthcare costs.
Comparison to Similar Drugs
Some experts state that Trasylol is much more harmful than Vioxx, an infamously dangerous painkiller pulled off the market in 2004.
Alternatives to Trasylol
Several alternative drugs exist that have comparable effectiveness to Trasylol in preventing blood loss during heart surgery, while displaying none of Trasylol's risk of heart attacks and other severe complications revealed by the 2006 study. These drugs, including tranexamic acid and aminocaproic acid, were already preferred by a number of physicians before the study because of their lower cost and perceived higher safety.
Consulting With an Attorney
Trasylol is a harmful drug that thousands of American patients have received. If you or a loved one was given Trasylol and later experienced a heart attack, kidney failure or stroke, contact an attorney immediately, as a statute of limitations restricting the length of time in which individuals may take legal action applies to all legal claims.
If you are determined to be eligible, your lawyer can give you expert counsel. You may be entitled to recover damages from medical bills, loss of income or the ability to work, suffering and mental anguish, loss of companionship or support, and more. Your lawyer will assist you in getting justice and compensation for your claim.