On September 12, 2007, the Food and Drug Administration (FDA) will begin its second safety review of Bayer’s heart bypass surgery drug Trasylol. The drug has been the focus of FDA investigation following two 2006 studies that suggested the drug doubles the risk of kidney failure, and two subsequent studies suggesting it also increases the risk of death.

In December 2006, the FDA assigned Trasylol its strictest black-box warning, stating the drug could increase the risk of kidney damage and should only be used in certain patients.

A newer study, known as the I3 drug report, was given to Bayer shortly before a September 2006 FDA meeting, but the company didn’t submit the results of the study until after the meeting. The most current safety review will take these results into consideration.

According to the FDA, the I3 drug study found Trasylol increased the risk of death by 54 percent. The agency said, however, that the study alone shouldn’t be used to determine the safety of the drug.

Also in 2007, a study published in the Journal of the American Association suggested Trasylol increased the risk of death by 50 percent for specific patients. This was a follow-up to a study that concluded patients receiving Trasylol showed a doubling of kidney failure.

Bayer said it appeared Trasylol was associated with renal dysfunction or kidney problems, but that it was not associated with an increased risk of death.

Source: “Jennifer Corbett Dooren, “Antibleeding heart bypass drug faces another FDA safety review,” Wall Street Journal, September 10, 2007.