Trasylol Side Effects

Trasylol, also known as aprotinin, received approval by the U.S. Food and Drug Administration (FDA) in 1993 for the purpose of reducing bleeding in patients undergoing cardiopulmonary bypass during a coronary artery bypass graft surgery. On November 5, 2007 the FDA recommended that Bayer temporarily stop marketing the drug after several medical studies revealed it increased the risk of kidney failure, strokes, heart attacks and death.

Bayer May Be Liable for Trasylol’s Harmful Side Effects

The manufacturers and marketers of pharmaceutical agents have a responsibility to protect consumers from potentially harmful or fatal side effects. To protect the public, these companies must fully evaluate potential side effects and inform physicians and patients about the injuries that could result from taking these defective drugs. During a September 21, 2006 meeting with the FDA regarding Trasylol’s dangerous side effects, Bayer scientists failed to disclose the results of an important study, which found that this defective drug increases the risk of strokes and death. If a company fails to properly protect the public, then they may be liable for any injuries caused by their drugs and could be required to provide compensation to these victims.

FDA Working to Phase out Trasylol

Trasylol has been administered to more than 1 million cardiac patients. The drug blocks an enzyme the body produces to destroy blood clots, thereby reducing blood loss. This is why it is used during cardiopulmonary bypass procedures, which often require blood transfusions. Unfortunately, Trasylol also can have severely damaging side effects, including death. As yet, the FDA has decided not to issue a full recall of the drug. This decision is partly due to the fact that few treatment options are available for patients at risk of excessive bleeding during cardiac procedures. The FDA is working with Bayer to slowly phase out the use of Trasylol in order to avoid shortages of the other drugs used to prevent blood loss.

The FDA began investigating Trasylol after two studies were released detailing its dangerous side effects. One study, published in the New England Journal of Medicine, found an increased risk of kidney failure, heart attack and stroke. The authors of the study speculated that recalling the defective drug could prevent as many as 11,000 cases of kidney failure a year and save more than $1 billion per year in dialysis costs, in addition to the nearly $250 million spent on the drug itself. These studies prompted the FDA to issue a warning for Trasylol noting the drug increased the risk of kidney failure and advising that it only be administered to certain patients, such as those at risk of extreme blood loss during surgery.

The FDA continued to study Trasylol in order to determine its risk to the public. It ultimately recommended that Bayer cease marketing Trasylol after an Ottawa Health Research Institute study showed that Trasylol posed a higher risk of death compared to the other two drugs used in the study. Bayer has subsequently complied with the FDA’s recommendation and Trasylol is no longer being manufactured, though it is still available for some patients.

Legal Recourse

The widespread use of Trasylol has unnecessarily exposed many people to increased risks of kidney failure, heart attacks, strokes and even death. If you or a loved one has suffered any of this defective drug’s side effects, you may be entitled to legal recourse. The lawyers of Levin, Simes, Kaiser & Gornick have decades of experience representing individuals in personal injury lawsuits similar to those currently being brought against Bayer. To learn more about your legal rights and the possibility of compensation, call (800) 901-4001.

Levin Simes Kaiser & Gornick, LLP
44 Montgomery Street, 36th floor
San Francisco, CA 94104

Ph: 1.800.901.4001
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