UPDATE 2-Regulator urges lifting Bayer heart drug suspension

Fri Feb 17, 2012 7:50am EST

* Says Bayer drug should be used in some heart surgery cases

* Trasylol suspended in 2008 after study

* Bayer says will await EU commission decision

* Bayer says sees its view confirmed (Adds Bayer comment, background)

LONDON/FRANKFURT, Feb 17 (Reuters) - The European drugs regulator has recommended lifting the suspension on Bayer's heart-surgery drug Trasylol, saying the results of a study that led to its being taken off the market were unreliable.

Trasylol, based on the active ingredient aprotinin, prevents excessive blood loss during surgery by halting the breakdown of fibrin, a protein found in blood clots.

The drug had been widely used since the 1990s during heart bypass surgery. Bayer pulled the drug globally in November 2007, after preliminary results of a Canadian study known as BART appeared to show an increased death rate in patients 30 days after taking the medicine.

That was followed by detailed assessments of the BART study by several health regulators across the globe.

The European Medicines Agency (EMA) on Friday concluded that there were a number of problems with the way the study was conducted and its findings had not been replicated in other studies.

It said the drug's benefits in preventing blood loss therefore outweighed its risks in patients undergoing isolated heart bypass surgery who were at high risk of heavy blood loss.

Asked whether Bayer was preparing a re-launch of the product, a spokesman said the company would await the European Commission's decision, based on the European Medicines Agency's recommendation, before considering any further steps.

"The recommendation confirms our view of the product's positive risk-benefit profile," the spokesman added.

As of February 2011, the latest available information from Bayer, there were about 1,100 lawsuits pending in the United States against Bayer with plaintiffs claiming Trasylol caused injury and death and Bayer should have known of the risks.

In September, Canada's health regulator had also lifted its temporary ban on Trasylol, saying that a detailed analysis of the BART study showed that the drug's benefits outweigh the risks. (Reporting by Paul Sandle and Ludwig Burger; Editing by Will Waterman and Hans-Juergen Peters)

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