Six years after it was hit by problems with the anti-cholesterol drug Lipobay/Baycol, German chemicals and pharmaceutical group Bayer said Monday it would suspend global sales of its anti-bleeding treatment Trasylol.
A statement by the maker of Aspirin said it had "elected to temporarily suspend worldwide marketing of Trasylol ... until final results from the Canadian BART trial can be compiled, received and evaluated."
The decision was taken following discussions with health authorities in Canada, Germany and the United States. The US Food and Drug Administration (FDA) recommended the drug be withdrawn, while German officials ordered it be done.
"Starting now, Trasylol must no longer be sold," said a statement by the German body BfArM, since there "exists a solid suspicion it could have damaging consequences in certain conditions."
The treatment is used to limit the risk of hemorrhage and blood loss and allow patients undergoing heart-bypass surgery to avoid transfusions. On October 25, Bayer announced that preliminary results from an independent Canadian study - known as BART and halted ahead of schedule - raised doubts about Trasylol, which was suspected of "an increase in all-cause mortality."
Four studies are currently underway, according to BfArM, to evaluate possible consequences associated with the treatment. Last year, two studies found an abnormally high incidence of cardiovascular, cerebral-vascular and renal accidents, but owing to problems with their methodology, reliable conclusions could not be published.
A Bayer statement said that evaluation of the Canadian data was "a process that is expected to take up to eight weeks, or perhaps longer." Sold since 1993 and 1999 in the United States and Germany, respectively, Trasylol contributed around 93 million euros to Bayer's nine-month results this year, a company statement said.
That included around 63 million euros in US sales and around 5.0 million in Germany. The drug had worldwide sales of about 338 million dollars (233 million euros) in 2005, but turnover dropped by about one-third last year, its report added.
In 2001, Bayer was rocked by problems with its anticholesterol drug Lipobay/Baycol, which was suspected in the deaths of more than 50 people. Bayer said at the time that its withdrawal would cost 900 million euros. On Monday, Bayer shares had nonetheless gained 1.52 percent to 57.51 euros in midday Frankfurt trading, while the DAX index of leading shares was 0.44 percent lower overall.
Investors appeared to have focused on a press report that elsewhere, Bayer would announce a 400-million-euro (580-million-dollar) cost-cutting programme in its plastics division.