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DRUG Information

DRUG MANUFACTURER:
Bayer Pharmaceuticals Corporation

DRUG NAME:
Trasylol, also known as aprotinin

DRUG INFO:
Trasylol, or aprotinin, a product derived from bovine lung tissue, is a clotting drug that was injected during heart surgery to prevent bleeding.

RECALL INFO:
Trasylol has been pulled from the U.S. market due to safety concerns of the Federal Drug Administration (FDA).

FDA Requests Marketing Suspension of Trasylol
FDA Web site — November 5, 2007

Questions and Answers on Aprotinin (marketed as Trasylol)
FDA Web site — Last updated May 20, 2008

 

Trasylol News

Bayer Halts Sale of Drug Used in Heart Surgery:
Trasylol Linked to Deaths After Procedure
Washington Post — November 6, 2007

 

 

 

Trasylol (Aprotinin) Recall

TRASYLOL PULLED FROM MARKET: Recalled drug can cause death, kidney failure, stroke, or heart attack

On November 5, 2007, the makers (Bayer Pharmaceuticals) of Trasylol removed the drug from the U.S. market because of safety concerns of the Federal Drug Administration (FDA). On the market since 1993, the drug was used in thousands of open heart surgery procedures, and is likely to have injured or killed an unknown number of patients.

Topics on this page:

• What is Trasylol?
• Who was exposed to Trasylol?
• Types of Injuries Caused by Trasylol
• Contact an Experienced Personal Injury Attorney

 

What is Trasylol?

Trasylol, also known as “Aprotinin,” is a blood clotting drug that was frequently used in open heart surgeries to prevent excessive bleeding and to minimize the need for transfusions. Trasylol is made from the lung tissue of cattle and it works by blocking enzymes that thin the blood or dissolve blood clots. 

Trasylol manufacturer Bayer Pharmaceuticals, pulled the drug from the market in 2007 after studies showed that patients exposed to Trasylol during surgery faced a 50% increased risk of death compared to patients receiving other clotting drugs.

Although there were other, safer and cheaper clotting drugs on the market, Bayer actively marketed this much more expensive and dangerous drug until it was finally forced to remove the drug from the market due to FDA recommendations.

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Who was exposed to Trasylol?

Patients having open heart surgeries such as coronary artery bypass grafting (CABG) or heart valve repair or replacement were likely to have Trasylol exposure. Almost all exposure to Trasylol occurred when physicians administered it during the course of lengthy open heart surgery procedures, because of the potential for significant blood loss. Physicians used Trasylol to encourage blood clotting and prevent excessive bleeding.

Unfortunately, the same clotting mechanism that prevented bleeding also caused irreversible injury to the kidneys, or created clots that resulted in strokes or heart attacks.  

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Types of Injuries Caused by Trasylol

Kidney (Renal) Failure 

One of the most common medical complications caused by Trasylol is kidney or renal failure. Within days or weeks of normally successful heart surgery, recovering patients would develop kidney failure. These patients were placed on renal dialysis, and many died when their kidneys and other organs shut down completely.

 

Stroke

Because Trasylol causes the blood to “thicken” or clot more easily, some patients developed blood clots (thrombus) that traveled to the brain, causing severe injury or death.

These are known as “ischemic” strokes because a clot travels to the brain or forms in the brain, causing a blockage in the arteries feeding blood to the brain. Trasylol does not cause “hemorrhagic” strokes, which occur when a blood vessel ruptures and bleeds into the space between the brain and the skull.

 

Heart Attack 

The same Trasylol clotting mechanism that causes strokes, has also caused exposed patients to experience post-surgical heart attacks. A heart attack occurs when the blood supply to the heart muscle is severely reduced or blocked.

The interruption of the blood supply happens when one or more of the coronary arteries supplying blood to the heart are blocked. Studies published in 2006 by the New England Journal of Medicine and the journal Transfusion reported that patients who were exposed to Trasylol during surgery had a 55% increased risk of heart attack or heart failure.

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Contact an Experienced Personal Injury Attorney

If you or a loved one has been injured because of exposure to Trasylol (aprotinin injection) during surgery, especially if you have suffered kidney failure and have needed dialysis, you may be entitled to compensation for:

• Medical treatment
• Hospitalization
• Lost wages
• Pain and suffering
• Other damages arising from your exposure 

If a loved one has died because Trasylol was used in surgery, you may be entitled to wrongful death compensation or compensation to the estate.

KCR personal injury attorneys have handled thousands of cases involving defective and dangerous drugs such as Trasylol. In recent years, KCR has litigated and settled numerous nationwide cases involving dangerous drugs and medical devices and products such as:

• Vioxx
• Phen-Fen diet drugs
• Intergel anti-adhesion surgical product
• Guidant defibrillators and pacemakers

We have the specific knowledge and expertise to help our injured clients obtain fair compensation in these complex cases. Some of the recent cases we've resolved include:

• $240 Million Guidant Defibrillator Settlement — KCR clients who were injured by malfunctioning Guidant cardiac defibrillators will claim shares of the $240 million fund as part of a 2008 nationwide settlement.
  
  
• In a confidential settlement, our attorneys successfully resolved a case against Johnson & Johnson on behalf of over 200 individuals who alleged that they contracted post operative infections from sutures that had not been properly sterilized.
  
  
• In another case, we successfully resolved a case against a Johnson & Johnson subsidiary, Ethicon, Inc. on behalf of approximately 56 women who allege that they were injured by a defective medical device known as Intergel.

If you or a loved one has been injured because of exposure to Trasylol (aprotinin injection) during surgery, please fill out and submit the contact form on this page for a free case evaluation or call us toll-free at (888) 285-3333.

 

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