Bayer Surgery Drug Should Stay on Market: FDA


Bayer's heart surgery drug, Trasylol, linked in some studies with an increased risk of death, should remain on the market, advisors to the U.S. Food and Drug Administration said on

The panel of health experts voted 16-1 to keep the drug used to stem bleeding during heart bypass surgery on the market after considering new data on an increased risk of mortality.

The advisory group was asked to again review the safety of Trasylol because days after a similar panel concluded in September 2006 that the drug was safe for some patients, data unexpectedly emerged from Bayer that suggested an increased risk of death.

The FDA usually takes the advice of its expert panels.

"It seems a bit foolhardy to me to throw the baby out with the bathwater," panel member Dr. Lynn Warner-Stevenson, of Brigham and Women's Hospital in Boston said, noting the drug's benefits in stemming the need for blood transfusions.

Panel members said the data suggesting mortality risk, although troubling, was not strong enough to warrant pulling the drug from the market or changing its label to note them. The studies were so-called observational studies and not the gold standard of randomly-controlled clinical trials typically used to win new drug approval.

The panel also voted that such a vigorous trial should be conducted to further assess the risks and benefits of Trasylol. Such studies would be voluntary because the FDA cannot mandate them, officials acknowledged.

Several panel members lamented the fact the FDA cannot require the suggested trials.

"I voted yes (to keep the drug on the market) but I still have a lot of unease," about the drug's safety, said panel member Dr. Alfred Cheung of the University of Utah.

Bayer Apologizes

German drugmaker Bayer earlier apologized for mistakenly withholding a study of 67,000 hospital records suggesting the drug might boost the risk of death, serious kidney damage, congestive heart failure and stroke. 

"On behalf of Bayer, I would like to personally apologize for this error," Kemal Malik, Bayer's head of global development and board member, told panel members.

Bayer argued that the controversial hospital record study, which it commissioned, was flawed and could not be relied upon. The company suspended two senior staffers over the issue, and a representative said they were the only employees aware of the data prior to the original panel meeting.

Dr. Dennis Mangano, founder of the Ischemia Research and Education Foundation and co-author of several published studies linking the drug with increased long-term mortality and kidney problems, advised against continued use of the drug.

He cited data showing two generic drugs to be just as effective, with less risk of kidney problems.

"Continued use is not prudent," Mangano concluded.

Trasylol, known generically as aprotinin, won U.S. clearance in 1993. Two other older, generic drugs are often used for the same purpose.

The original September 2006 FDA panel meeting reviewed data from medical journals that suggested the drug might increase the chance of kidney damage, heart attacks and strokes. That panel concluded the drug was safe in some patients.

Trasylol's label was revised in 2006 to narrow its use to patients with an increased risk of blood loss and transfusion. That has seriously eaten into use of the drug, analysts have said, dramatically cutting annual sales forecasts that once topped $500 million.

About 430,000 coronary artery bypass surgeries were performed in 2004 in the United States, the last year reported by the American Heart Association.

Bayer has said that between 10% to 20% of all blood transfusions in the United States occur during heart surgery.