The anti-bleeding drug Trasylol was recalled in early November after a study revealed the risk of death was 50 percent higher than on other drugs. The BART study examined results on over 3,000 patients that had been given Trasylol and two similar drugs. The Commission on Human Medicine decided this week to suspend Trasylol’s license.
The CHM decision to suspend the licence was made on the basis of preliminary findings from a clinical trial (the BART study), which was stopped early after excess mortality was observed in the aprotinin arm compared with the tranexamic acid and aminocaproic acid arms (relative risk 1.5).
Trasylol has been used around the world in open heart sugeries to reduce bleeding complications. It has been linked to kidney failure, heart attack and stroke. There have been several recent studies questioning the safety of Trasylol.
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