UPDATE: Trasylol Sales Halted
November 5, 2007 – Bayer announced that worldwide sales of Trasylol have been halted in response to concerns over a possible increased risk of death. The decision was made in light of results from a Canadian-led clinical trial involving 3000 cardiac patients. All were undergoing either a coronary heart bypass graft, aortic valve replacement, or a combined valve-graft procedure. Generically known as aprotinin, Trasylol is used to prevent excessive bleeding during cardiac surgery. Since January of 2006 safety concerns have arisen regarding the drug’s propensity to cause serious side effects such as heart attack, kidney complications, and stroke.
Trasylol, a drug commonly used during heart surgery to control bleeding, has been linked to a significantly increased risk of serious side effects including cardiovascular injury, kidney toxicity and death. If you or a loved one has suffered serious injury following cardiovascular surgery and you know or suspect that Trasylol was administered during the procedure, please contact us to speak with a qualified Trasylol attorney who can answer your questions and determine if you may be eligible to seek compensation for your losses and suffering.
What is Trasylol?
In 1993, the Food and Drug Administration approved Trasylol (also known by its generic name aprotinin or aprotinin injection) to prevent blood loss and the need for transfusion during cardiopulmonary bypass (CPB) in the course of coronary artery bypass graft (CABG) surgery. This is the only drug approved for this purpose. Trasylol (aprotinin), a proteinase inhibitor, is made from the lung tissues of cattle.
The drug, produced by Bayer AG, has been administered to millions of patients who have undergone heart surgery over the past 13 years. Studies now reveal that this drug poses serious risks and has caused severe injury to thousands of patients.
Trasylol Side Effects
In January 2006, the FDA began conducting a comprehensive safety assessment of Trasylol in reaction to two published scientific studies. The first of these studies, published in the New England Journal of Medicine on January 26, 2006, compared the effects of Trasylol/aprotinin to the effects of two generic alternatives to Trasylol: aminocaproic acid and tranexamic acid.
Of the over 4,000 heart surgery patients involved in this study, some were given Trasylol, some given a generic alternative, and others given no medication at all.
Researchers at the Ischemia Research and Education Foundation discovered that patients given Trasylol (aprotinin) were approximately two times more likely to suffer one of these serious side effects:
- Heart attack (myocardial infarction)
- Heart failure
- Renal dysfunction and kidney failure
Another study published in the medical journal Transfusion, also released in January 2006, discovered a significant increase in the risk of renal toxicity in patients who received Trasylol/ aprotinin during while undergoing heart surgery.
Experts report that if doctors stopped administering Trasylol to their patients,
10,000 to 11,000 cases of kidney failure could be prevented annually
One billion dollars in healthcare expenses (dialysis costs) could be saved
And $250 million in drug expenses could be spared (since Trasylol is far more expensive compared to its generic alternatives).
Trasylol Investigation and Bayer’s Failure to Inform
Researchers believe that these risks went unnoticed for so long because Bayer failed to conduct sufficient studies regarding the safety and efficacy of their heart surgery drug. Drug manufacturers are legally required to conduct a series of comprehensive clinical studies to determine the safety and efficacy of their products. These companies also have an obligation to report any possible side effect risks associated with their drug to the FDA, doctors and patients.
On September 20, 2006, the FDA held an Advisory Committee meeting on Trasylol safety in light of the recent medical evidence linking the drug to serious and life-threatening side effects. A few days later, Bayer publicly admitted that they withheld information about Trasylol clinical results from the FDA. Finally, on September 27, 2006, Bayer told the FDA that it had conducted an additional safety study of Trasylol.
This new Trasylol study was conducted by a research organization contracted by Bayer. After examining the records of 67,000 patients who underwent coronary artery bypass graft surgery (CABG), about half of which received Trasylol and half of which received alternatives, researchers for Bayer concluded that Trasylol significantly increases the risk for stroke, congestive heart failure, kidney failure, and death.
Baffling FDA Reaction to Trasylol Risks
Despite acknowledging that Trasylol poses serious and deadly side effect risks, the FDA has concluded that this drug will remain on the market. The agency states that, in some cases, the benefits of this drug might still outweigh the side effect risks. This conclusion is puzzling given that studies indicate safer and less expensive alternatives are available.
What to Do If You Have Suffered a Trasylol Injury
Bayer AG has made billions of dollars off a dangerous drug. They concealed important Trasylol safety information from the FDA and from consumers. The company continues to market a drug that they know is dangerous and potentially deadly.
If you or a loved one has suffered a Trasylol injury such as kidney failure, heart attack, stroke, heart failure, or death, you have the right to seek compensation for your losses and suffering. Through a Trasylol lawsuit, you may be able to obtain restitution for your past and future medical expenses, loss of income and earning potential, reduced lifespan, pain and suffering, and more.
Please contact us to speak with a qualified and experienced Trasylol attorney who is prepared to fight those responsible for your losses and suffering and help you receive the compensation you deserve. We offer a free, confidential, no-obligation consultation so that we can review your case together and determine the best way to protect and maximize your legal rights and options. Call us at 1-800-400-8182 or contact us online today.