Finding study flaws, EMA backpedals on Trasylol suspension
European regulators are second-guessing their decision to suspend the Bayer heart-surgery drug Trasylol. The study that persuaded the European Medicines Agency officials to keep Trasylol off the market? Well, it may not be as reliable as they first thought.
The story begins in 2007, when Canadian researchers found that Trasylol patients appeared to die at an increased rate after surgery, compared with patients who weren't given Trasylol. The study, known as BART, prompted Bayer to pull the drug off the market around the world. Then, regulators did their own digging into the data.
As Reuters reports, EMA now believes that the BART study had some significant flaws. What's more, additional studies haven't confirmed the BART findings. So, the benefits of Trasylol actually do outweigh its risks in patients at high risk of heavy blood loss, the EMA has concluded.
The European Commission will have to decide whether to act on EMA's determination before Bayer could re-introduce the drug. A spokesman told Reuters that EMA's "recommendation confirms our view of the product's positive risk-benefit profile." But the company will wait to hear from the EC before taking any steps toward a Trasylol relaunch, he said.
The EMA's recommendation comes after Canada's health regulator lifted its ban on Trasylol, saying its analysis of BART showed the drug's benefits outweigh its risks. And it follows several years of litigation in the U.S., where more than a thousand patients have sued; Bayer settled at least 200 of those lawsuits, but as of last February, about 1,100 remained unresolved.
- read the Reuters news