Drug to Stay on Market Despite Risk of Kidney Failure, Death


On September 13, a Food and Drug Administration (FDA) panel of independent medical experts voted to keep Trasylol, a drug marketed by Bayer AG, on the market in the US.

As part of a continuing review, the panel was given the opportunity to review all pertinent data and determine whether the drug was safe enough to be used or whether it should be pulled. Since 2006, four studies have linked the drug, which is used to control bleeding in patients undergoing heart-bypass surgery, with kidney failure and even death.

Two studies published in 2006 showed that the drug doubled the risk of kidney failure in patients, while two additional studies have suggested that it might be linked to increased death risk. In one study, the increased risk was 50%, while in another the increase was 54%. The FDA warning for the drug also notes the possibility of severe anaphylactic reaction if administered to a patient more than once in a 12-month period.

In the face of this information, the panel voted overwhelmingly by 15 to 1 with one abstaining to keep the drug on the market.

Apparently, panel members believed that the data, especially from the anaphylactic reaction studies, was too slight to merit pulling the drug from the market. They pointed to the fact that Trasylol is the only antibleeding product specifically approved for use in cardiac surgery, although other antibleeding products are available.

Although some of the data had been available to Bayer before the panel’s 2006 meeting, Bayer did not immediately hand over the report, although the company denies withholding the information, but was careful to state in protective language that senior management had not been told the data was in until after the FDA panel met.

In keeping the drug on the market, panel members recommended that additional studies should look at safety concerns connected with the drug. Apparently, not enough people have died to make a convincing statistic.

Despite recent health debacles over drugs like Vioxx, Prempro, and the Ortho Evra birth control patch are insufficient to convince regulators to step in earlier rather than later. Let the companies fiddle while we burn, they say, because they know that we are the ones who pay the fiddler.

Bayer says Trasylol “is an important part of blood conservation programs” during heart bypass surgery. Perhaps we could get the drug off the market more easily if the blood supply were more secure: a good reminder that we should all donate blood whenever possible.

And we should also use our only recourse when drug companies and regulators conspire to keep dangerous drugs on the market: the courts. If you or someone you love has experienced undue or unexpected side effects from taking a drug, contact PersonalInjury.com to find an experienced drug side effects lawyer to help you receive compensation for your loss and penalize pharmaceutical companies who push bad drugs.