Here's some somber news: The FDA has tallied more than 200 reports of deaths linked to Trasylol, the suspended blood-clotting drug made by Bayer. Since 1993, when the drug was approved, doctors and other healthcare providers reported the deaths of 235 patients who received Trasylol during heart-bypass surgery.
There's no proof that Trasylol caused every one of these deaths. But you'll recall that Canadian regulators halted a clinical trial when early data seemed to show Trasylol might raise the risk of death by 50 percent. FDA then told Bayer to withdraw the drug while agency researchers pored over this new information.
This latest brouhaha follows a dust-up last year, when an FDA panel met to review data that linked Trasylol to a higher risk of death, kidney and heart failure, and stroke. The panel voted to keep the drug on the market, but then a whistleblower tipped off the FDA that Bayer had hidden an additional study about those risks. Bayer conducted an investigation and concluded that the info just fell through the cracks because of "human error."
Now Bayer has posted that study on its Trasylol website. It's not very encouraging. The researchers concluded that patients given Trasylol were more likely to die or experience kidney failure than were patients given aminocaproic acid. And the increased risk couldn't be attributed to the fact that more high-risk patients were given Trasylol.