Monday November 5, 12:48 PM
German pharmaceutical group Bayer suspends sale of blood-clotting drug
FRANKFURT (AFP) - German chemicals and pharmaceutical group Bayer (Xetra: 575200 - news) said Monday it would temporarily pull its blood-clotting injection treatment Trasylol from markets around the world.
A statement said the maker of Aspirin had "elected to temporarily suspend worldwide marketing of Trasylol ... until final results from the Canadian BART trial can be compiled, received and evaluated.
The Canadian trial had uncovered evidence that Trasylol, designed to limit blood loss and allow patients undergoing heart-bypass surgery to avoid transfusions, "may be linked to a higher risk of death than that of competing drugs," the Wall Street Journal reported earlier Monday on its Internet site.
The newspaper quoted unidentified people with knowledge of the matter.
Bayer said in its statement that it "will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol."
Evaluation of the Canadian data was "a process that is expected to take up to eight weeks, or perhaps longer," the statement said.
The German pharmaceutical giant was also working with the US Food and Drug Administration (FDA) and other national health organisations on programmes to identify patients that might still benefit from the treatment during its suspension.
"Bayer will work with the FDA, Health Canada, and any other authorities who wish to institute similar programmess, to outline appropriate patient profiles and the specific details," the group said.
The FDA urged doctors in February 2006 to closely monitor patients taking the drug, which "has been tied to high-profile safety concerns," the Wall Street Journal had said.
The drug had worldwide sales of about 338 million dollars (233 million euros) in 2005, but sales dropped by about one-third last year, its report added.
In 2001, Bayer was slammed by the withdrawal of its anti-choloesterol treatment Lipobay/Baycol, which was suspected in the death of several patients.
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