Trasylol Studies Terminated

January 30, 2007, 12:00AM. By Jane Mundy

Boston, MAIn response to FDA-approved label changes for Trasylol, Bayer HealthCare has announced it will terminate three studies meant to expand the use of the drug. Trasylol is used to reduce blood loss during coronary artery bypass surgery.

The studies included examining the effectiveness of the drug in patients undergoing elective spinal fusion surgery, pneumonectomy or esophagectomy for cancer, and radical or total cystectomy in bladder cancer.

A recent change to the US labelling for the drug states that Trasylol should be administered only in surgical settings where cardiopulmonary bypass (CPB) can be rapidly initiated, and Bayer says that "the use of CPB is not practical in non-cardiac surgical settings." The drug's labelling is currently under review in Europe.

Bayer also stated that the decision was not based on any safety findings in these non-coronary artery bypass graft surgery studies and cited a report from a data monitoring panel in November, saying that the trials, which had involved 120 patients "could continue as planned without modification."

Trasylol has caused Bayer a few problems these past few years.

In February 2006, The Food and Drug Administration issued a Public Health Advisory alerting doctors who perform heart bypass surgery, and their patients, that Trasylol had been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks and strokes in patients who undergo artery bypass graft surgery.

But Bayer disputed the FDA findings, saying that it had just become aware of the potential risks and needed time to study it, and that they "will make recommendations for best use as soon as possible." Not soon enough for some patients.

In September, the FDA held a public meeting to discuss the safety and overall risk-benefit profile for Trasylol and made recommendations for labeling changes. At that meeting, Bayer representatives withheld critical information from FDA health officials to address health concerns over Trasylol. Bayer admitted that it should have disclosed the results earlier and suspended two senior staff members as a result of the incident.

Bayer HealthCare, a subsidiary of Bayer AG based in Germany, added that its decision to discontinue the studies was not based on any safety findings. Meanwhile, Bayer reached an $8 million settlement agreement with 30 US states that alleged the company failed to adequately warn consumers about risks associated with its cholesterol-lowering drug, Baycol (cerivastatin), which was withdrawn from the market in 2001.

In December, the FDA approved revised labeling for Trasylol to strengthen its safety warnings and to limit its approved usage to specific situations. Trasylol has caused fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial (test) dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial (test) dose was tolerated.

It has been estimated that Trasylol may have been administered to more than one million patients since FDA approval 13 years ago.