A drug used to stop excessive bleeding during bypass surgery should stay on the market in the USA despite being linked to an increased risk of death and serious side-effects, an FDA committee has ruled.
Bayer’s Trasylol® (aprotinin) was approved by the FDA in 1993 to prevent the need for blood transfusions.
Now a panel of FDA expert advisers has voted 16-1, with one abstention, to recommend allowing continued sales of the drug, which works by blocking enzymes that dissolve blood clots.
The FDA is not bound to follow the advice of its advisory committees, but does so most of the time.
The FDA has been re-evaluating the drug’s safety since two studies in January 2006 linked it to serious side-effects, including stroke, kidney problems and heart attacks.
Other more recent studies have suggested the drug increases the risk of death.
The findings of one of those trials were withheld from the FDA by Bayer in what a company investigation later called a “regrettable human error”.
Bayer maintains Trasylol can reduce the risk of blood transfusion, although it admits the drug appears to be associated with kidney problems.
But it is adamant that any link to kidney failure is less definitive, and that data do not show any associated increased risk of death.
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