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Published on Nov 05, 2007 by Edgar Snyder

Renal Failure or Kidney Damage After Heart Surgery May Result From Trasylol

Trasylol suspended from market

Bayer Removes Remaining Trasylol from U.S. Market

May 19 2008 UPDATE – The antibleeding medication Trasylol has recently been the subject of safety concerns since reports have confirmed earlier findings that the dangerous drug is associated with an increased risk of death in heart surgery patients. Trasylol's manufacturer, Bayer AG of Germany, has announced that it will remove the remaining stock of Trasylol from the U.S. market.

Bayer suspended sales of Trasylol last November when clinical trials found that the medication increased a patient's chance of dying after heart surgery. Bayer is removing remaining Trasylol stock from warehouses, hospitals, and pharmacists' inventories.


URGENT ALERT – If you or someone you know suffered kidney damage or renal failure after heart bybass surgery, it may be related to the dangerous drug Trasylol. Most patients are not even aware of the fact that they received Trasylol when they were in the hospital.

May 15 2008 UPDATE – Bayer AG's antibleeding medication, Trasylol, has already been deemed a dangerous drug and was pulled from the market last year. The findings of a recently released study about the drug's adverse side effects may permanently ban the sale of the medication.

Bayer temporarily suspended sales of Trasylol in November at the request of the Food and Drug Administration and other regulators. At the time, a Canadian clinical trial suggested that the unsafe drug was associated with a higher risk of death than other medications in high-risk heart surgery patients. Bayer agreed to freeze sales until the results of the trial, called BART, were finalized.

Those results, published in the New England Journal of Medicine, confirmed previous findings. Trasylol increases the relative risk of death by 50 percent in heart surgery patients. Furthermore, the study found that Trasylol's ability to decrease massive bleeding does not outweigh the serious safety risks of the medication. Bayer has not said whether or not Trasylol will return to the market. So far, U.S. patients have filed 83 lawsuits against Bayer over Trasylol.


Nov 2007 ORIGINAL ALERT –The Food and Drug Administration (FDA) has reached an agreement with the makers of Trasylol, a prominent blood loss drug used in heart bypass surgery, to suspend sales in the United States. The FDA has requested that Bayer Pharmaceuticals halt marketing of Trasylol after a recent study found that the drug had an increased risk of death compared to other medication.

While researchers disclosed that Trasylol had a lower rate of serious bleeding events, data found that the drug caused a higher risk of death, increased rate of hemorrhage, and kidney damage. The study was performed by the Ottawa Health Institute, which stopped it before completion after finding Trasylol’s increased trend towards patient mortality.

The FDA has announced it will review data from the terminated Canadian study to determine if the benefits of Trasylol outweigh the risks. In the meantime, the suspension of marketing and sales of Trasylol will be gradual in order to avoid shortages of competing blood loss drugs.

Please note: All of our lawyers are licensed to practice in the state of Pennsylvania. We also have lawyers licensed to practice in Maryland, Ohio, Virginia, and West Virginia, and we associate with experienced attorneys in other states. In addition, all drug-related litigation may involve co-counsel.

Sources:
"FDA Requests Marketing Suspension of Trasylol." FDA Alert. November 5, 2007.
"Bayer Suspends Sales of Trasylol." By Anna Wilde Mathews. Wall Street Journal. November 5, 2007.
"Bayer Antibleeding Drug Takes Hit." The Wall Street Journal. May 15, 2008.
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