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Published on 7 November 2007

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FDA suspends Trasylol authorisation

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The Food and Drug Administration (FDA) has suspended Trasylol (aprotinin) pending a review of preliminary results from a Canadian study that found an increased risk of death.

Manufacturer Bayer Pharmaceuticals has agreed to the decision on the drug, which is used to control bleeding during heart surgery. The FDA requested the suspension in the interest of patient safety based on the study, but it has not yet received the full findings.

It will now work with Bayer, the study’s researchers at the Ottawa Health Research Institute, and other agencies on a thorough analysis of the data in a bid to understand the risks and benefits of taking Trasylol.

There are only a few treatments available for patients at risk for excessive bleeding during cardiac surgery, so the FDA is working with Bayer to phase Trasylol out of the market in a way that does not cause shortages of other drugs used for the condition.

The Ottawa Health Institute stopped the study on Trasylol because the drug appeared to increase the risk of death compared with two other antifibrinolytic drugs used in the research.

Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding.

The preliminary data from the study also suggested that fewer patients receiving the drug experienced serious bleeding.

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© PA Business 2007

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