FDA Panel Votes to Keep Bayer Drug on the Market
WASHINGTON – A Food and Drug Administration panel of outside medical experts said a Bayer AG drug, used to control bleeding in patients undergoing heart-bypass surgery, should stay on the U.S. market.
The drug, Trasylol, has been the subject of a continuing FDA safety review since two studies published in 2006 suggested that the drug doubled the risk of kidney failure. Since then, two additional studies have suggested that the drug also could increase the risk of death.
Many panel members said they were concerned that the newer data, however, weren’t strong enough to merit pulling the drug from the U.S. market.
Several panel members also noted there is no other antibleeding product specifically approved for use in cardiac surgery.
The panel voted 15 to 1 in favor of keeping Trasylol on the market, while one panel member abstained from voting.
“We need to provide something in the label to say we are worried about it,” said panel member Michael Lincoff, of the Cleveland Clinic Foundation, in discussing the concern about a possible increased risk of death. He and other panel members said the studies only suggest a problem and don’t prove an increased risk of death from Trasylol.
The FDA said one of the most recent Trasylol studies, known as the I3 drug-safety study, shows Trasylol is associated with an increased risk of “death, renal [kidney] failure, heart failure and stroke.”
George Shashaty, a medical officer in the FDA’s division of medical imaging and hematology products, told the panel that the benefit of Trasylol is that the drug has been shown to reduce blood loss during surgery and to reduce the need for blood transfusions.
In December, the FDA updated its strictest black-box warning on Trasylol, stating that it could increase risk of kidney damage and that it should be used only in certain situations in which patients are at an increased risk for blood loss during heart-bypass surgery.
That decision followed an FDA panel meeting in September of last year.
The I3 drug report has been an issue because Bayer had the preliminary results in hand before the panel meeting last year but didn’t give the results to the agency until after that meeting. Bayer has said that it didn’t intentionally keep the results from the panel and that senior management wasn’t told the report was ready until after the FDA panel met.
Preliminary results from the I3 drug study found that Trasylol increased the risk of death by 54%, the FDA said.
But the agency said that study alone shouldn’t be used to determine whether the use of Trasylol is safe because the report was an observational study that looked at outcomes of patients undergoing heart-bypass surgery in hospital databases rather than being a controlled clinical study designed to specifically look at mortality and other safety questions.
The agency said Bayer recently submitted final results of the I3 study, and an agency review of those results is continuing.
Earlier this year, another study, published in the Journal of the American Medical Association, suggested that the drug increased the risk of death by about 50% for a certain group of patients.
That study was a follow-up to one of the 2006 studies that showed a doubling of kidney failure among patients receiving Trasylol.
Bayer said it did appear that the drug was associated with “renal dysfunction,” or kidney problems, but added the product didn’t appear to be associated with an increased risk of death, kidney failure or cardiovascular problems.
Pamela Cyrus, Bayer Pharmaceuticals vice president of U.S. medical affairs, said Trasylol “provides important benefits” for patients undergoing heart-bypass surgery and said the company is “convinced the benefits” of the drug outweigh the risks.
