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FDA Requests Marketing Suspension of TrasylolTrasylol Kidney Failure Victims

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The FDA announced on November 5, 2007, that Bayer Pharmaceuticals Corp. will cease the marketing and sale of Trasylol. This drug, which is used to control bleeding during heart surgery, must now undergo a detailed review of test results from a Canadian study. The BART sutdy revealed an increased risk for death from use of Trasylol (generically known as aprotinin).

The FDA issued its request to Bayer in order to maximize patient safety. Given that the side effect, death, is of the most serious nature, the FDA is being very cautious based on the preliminary BART study data. While the FDA, as of November 5, 2007, has not been provided with the full study data, to expects to act aggresively with Bayer, the Ottawa Health Research Institute, and regulatory agencies to perform a detailed analysis of data.

"Our experience tells us that when a drug is pulled in the middle of a study, and the study is terminated due to the negative side effects, that the risk assocaited with the danger is usually very significant. Once the FDA and the public are provided with the study data, we will better be able to understand the risks and benefits of Trasylol," said Jim Ronca, Esquire, the attorney at Anapol Schwartz handling the Trasylol cases.

There are alternatives to the drug Trasylol, although there not many treatment options. This means that the FDA must continue to work with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

Our Trasylol lawyers believe that once FDA sees the data from the BART study, it will determine and identify when Trasylol could still be used. That will only be in more rare cases than Trasylol is currently used. Only when the benefits of Trasylol outweigh the risks, will this drug be permitted to be used. This will require individual doctors to identify specific cases where benefit outweighs risk. The public should expect a limited use of Trasylol in the future.

These actions, by the FDA, follow notification by the Ottawa Health Institute, which stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study.

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TRASYLOL LAWSUIT INFORMATION

Date of surgery:
Have you (or injured party) experienced any of the following? (check all that apply)
Kidney failure
Stroke
Heart attack
Heart failure
Encephalopathy/brain disease
Death
Did you (or injured party) require dialysis? Yes No
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