A Food and Drug Administration panel has said that Bayer’s controversial Trasylol, which is used to reduce blood loss during heart surgery, should continue to be sold in the USA, despite the potential health risks.
The agency’s Cardiovascular and Renal Drugs and the Drug Safety and Risk Management Advisory Committees has backed Trasylol (aprotinin) following an ongoing review since two studies published in 2006 suggested that the drug doubled the risk of kidney failure. Since then, two other studies have suggested that it could also increase the risk of death.
However panel members deemed that the newer data is not strong enough to merit pulling the drug, especially as there is no other anti-bleeding product specifically approved for use in cardiac surgery. They voted 15 to one in favour of keeping Trasylol on the market but recommended that Bayer amend the US product label to provide additional prescribing guidance to physicians and also recommended that Bayer conduct additional clinical studies, including randomised controlled trials, to further assess the risk and benefit of Trasylol.
The decision was welcomed by Bayer which has suffered some embarrassment of late with the drug. Last month, the Leverkusen-based group revealed the findings of an independent lawyer’s investigation into the company’s failure to disclose data about the risks of Trasylol, which concluded that no cover-up was involved. In October last year, Bayer acknowledged that it failed to keep the FDA informed of data that could have had a bearing on the outcome of an advisory panel meeting looking at the safety of Trasylol.