FDA panel keeps Trasylol on market
A U.S. FDA panel of outside medical experts said that the Bayer drug, Trasylol – used to control bleeding in patients undergoing heart-bypass surgery – should stay on the U.S. market, according to the Wall Street Journal (WSJ).
The FDA has continued to review the safety of Trasylol since two studies published in 2006 suggested that the drug doubled the risk of kidney failure. Since then, two additional studies have suggested that the drug also could increase the risk of death, according to the WSJ.
The panel members voted 15 to 1 in favor of keeping Trasylol on the market, and one abstained from voting.
They also recommended that additional studies take place to examine safety concerns about Trasylol, and that the drug's label be updated to address a potential concern of an increased risk of death.
The FDA has continued to review the safety of Trasylol since two studies published in 2006 suggested that the drug doubled the risk of kidney failure. Since then, two additional studies have suggested that the drug also could increase the risk of death, according to the WSJ.
The panel members voted 15 to 1 in favor of keeping Trasylol on the market, and one abstained from voting.
They also recommended that additional studies take place to examine safety concerns about Trasylol, and that the drug's label be updated to address a potential concern of an increased risk of death.