Exactly a year ago, the FDA had Bayer strengthen the warning on its Trasylol medication which, until its recent marketing suspension, was used to reduce bleeding during bypass procedures. The move came after a particularly embarassing episode for the drugmaker - three months earlier, an FDA panel declared the drug was safe and effective, and voted unanimously to keep it on the market, despite growing concerns over higher risk of heart attacks and kidney failure. But only a few days later, it became known that Bayer hadn’t given the FDA a review of a giant database showing the same patterns.

So the Trasylol label was revised in order “to limit its approved usage to specific situations,” according to the FDA statement. Specifically, the new labeling said Trasylol should only be given to patients who are at an increased risk for blood loss and blood transfusion (emphasis added) while (undergoing) coronary bypass graft surgery, or CABG, a procedure used to improve blood flow to the heart. And this should only occur when patients also undergo cardiopulmonary bypass, or CPB, a procedure that allows a machine to take over the heart’s functions when it is stopped during surgery.

In other words, there was a very specific universe of patients in which Trasylol should have been used. But you may not have realized that by visiting the Bayer web site, specifically, the Trasylol page shortly after the December 2006 labeling revision and before the run-up to the most recent FDA panel meeting in September. During that time, Bayer’s main Trasylol page, which was touted as carrying ‘current Trasylol information,’ had this headline: “Trasylol for all (emphasis added) patients undergoing CPB for CABG surgery.” But that’s not what the labeling indicated. In reality, only a subset of a larger patient group qualified. The main Trasylol web page, however, gave a different impression. (Please look here).

To learn more about the actual wording of the labeling, one would have had to click on the prescribing info button on the top of the page. While that may have seemed easy enough, the complete and correct info should have been front and center for busy docs to absorb immediately. This was not a matter of semantics or a mouse click; this involved patient care in potentially life-threatening situations. Moreover, Bayer failed to present the appropriate info just weeks after agreeing to the labeling change that included a strengthened warning about the risks.

After all, when Bayer announced the labeling revision in its press release on Dec. 15, 2006, the drugmaker was explicit about emphasizing patient safety and informing docs about appropriate use: “Patient safety is Bayer’s primary concern and we believe updating the label and informing health care professionals about the appropriate use of Trasylol is very important.” The web site, however, gave a different impression.

When asked why Bayer used a headline on the Trasylol web page that was inconsistent with the revised indication, a Bayer spokeswoman wrote us with a vague reply: “The indication in the label was approved by the FDA and revised in December 2006. It was disseminated by Bayer through various means, including but not limited to posting on various Bayer internet sites including www.trasylol.com. Detailed information was included in addition to the revised labeling that directed visitors to the web site to the revised indication and other relevant information regarding the appropriate patient population, that being CABG patients at increased risk of blood loss and blood transfusion.” To be clear, she didn’t answer the question.

Why is this a problem, especially given that Trasylol is suspended for the moment? For one, the drug is being eyed in numerous deaths. Then there’s the notion of what consultants like to call ‘best practices.’ And don’t forget patient safety. “The info should be crystal clear and easily found. You’ve got to be scrupulously honest and accurate on your web site, and you need to do that on every page on your web site, especially when there’s controversy over your drug and its safety,” says Art Caplan, who heads the Center for BioEthics at the University of Pennsylvania. “To not do so is not only unethical, but it borders on the suggestion of liability.”