Trasylol

Trasylol

Bayer AG has withdrawn Trasylol from the global marketplace. About 4.8 million cardiac patients received the drug since it was first introduced almost 15 years ago.

Many of the patients experienced kidney failure, stroke and additional heart problems.

The drug is also known generically as aprotinin.

Trasylol was a drug used to mitigate excessive bleeding in patients undergoing types of heart surgery.

The drug came under scrutiny last year amidst the release of data relating to serious adverse effects.

A Canadian clinical trial was halted last month, after trial officials determined the risk to participants of irreversible damage, or death, was too great to continue.

Publicity surrounding a similar study, the results of which Bayer AG allegedly withheld from the US Food and Drug Administration (FDA) and Canadian regulators in 2006, only added to the suspicion that the drug was harmful.

The withholding of study results adjacent to a critical FDA panel vote governing Trasylol's continued presence in the placecountry-regionUS market was a result of regrettable human error, according to Bayer.

The Canadian study was designed to demonstrate that Trasylol was more effective than other drugs, according to the FDA's Gerald Dal Pan . "That study was halted, because Trasylol appeared to increase the risk for death compared with two other drugs."

Dr. John K. Jenkins, director of the FDA's Office of New Drugs, said that participants in the Canadian study were shown to have a 50 per cent increased risk for death, when compared with the other drugs in the study.

A study published last February in the Journal of the American Medical Association found that patients on Trasylol were at greater risk for dying over the next five years, than those on other drugs.

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