Yesterday the FDA announced that Bayer would be removing
remaining stocks of Trasylol after a study confirming suspected increased death
risks was published in the New England Journal of Medicine. The BART study compared
Trasylol with two less expensive alternatives on patients undergoing heart
surgery. In November the study was halted when preliminary results suggested
that patients being treated with Trasylol were dying at much higher rate than
those being treated with the other medications. This prompted Bayer to suspend
worldwide marketing of the drug until the results of the trial were finalized.
Final results of the study, published in this month’s New England Journal of Medicine, showed that patients being given Trasylol had a 53
percent increased risk of death over those treated with alternative
Bayer has informed the FDA that it will now remove remaining
stocks of Trasylol from the US market. Most of the stock is in warehouses,
doctors’ surgeries, and hospitals. The agency said it will work with the drug
company to ensure a “smooth and complete process”.
Trasylol was shown to be marginally more effective in
reducing bleeding; however, this small benefit in almost all cases will not
outweigh the risks associated with the drug. Some experts estimate that Trasylol
could have been responsible for as many as 1,000 deaths each month.
As of last week Bayer was facing 83 lawsuits over injuries associated
with Trasylol; this number will likely skyrocket in coming months. If you or a
loved one has been injured as a result of being administered Trasylol during
heart surgery, we would like to help you.