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Wednesday 26th October 2016

Bayer pulls heart-surgery drug

20th May 2008

Germany-based Bayer AG has announced it is pulling supplies of its heart-surgery drug Trasylol from the market after it was linked to a higher death rate than alternative treatments in a long-awaited follow-up study.


The move came shortly after a Canadian academic study was published in the New England Journal of Medicine. It showed that the drug, generically known as aprotinin, was linked to a 50% higher death rate among patients recovering from heart surgery, compared with patients who were given other drugs which cost less.

A leading researcher into the effects of a drug produced by Germany's Bayer has said that as many as 22,000 people could have been saved if drug regulators had acted faster.

The Food and Drug Administration (FDA) said Bayer had told the agency that it would begin removing remaining Trasylol stock from the US market. After that, it would be limited to patients with no acceptable alternatives.

The FDA said it supported Bayer's decision to completely remove Trasylol from regular use in the US market.

Researcher Dennis Mangano led a study probing the effects of Trasylol, which has now been linked to kidney failure resulting in the need for dialysis, and death. Trasylol is thought to have been given to as many as a third of all heart bypass patients in the United States over a period of many years.

The drug had probably now reached the end of the line, according to Wayne Ray and Michael Stein of Vanderbilt University in Tennessee.

Bayer pulled the drug in November, saying it would reevaluate its options once details from the new study, known as BART, were released.

Bayer said it would work with health authorities to determine what impact, if any, the BART data and any other new data will have on the benefit-risk profile of Trasylol.

Trasylol patients showed a 50% higher death rate 30 days after heart surgery, with more patients in the Trasylol group experiencing cardiac symptoms.

Pfizer's Cyklokapron (tranexamic acid) and Xanodyne's Amicar (aminocaproic acid) were not quite as effective at controlling bleeding, the BART study found, but were linked to much lower death rates.

Aprotinin costs almost 10 times as much as its safer rivals. The study looked at patients who were considered the best candidates for aprotinin.


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