Bayer’s Trasylol facing FDA questions but remains a proper option for certain heart surgery patients, physicians say

- Finacial Times

09/12/2007 - Bayer’s Trasylol (aprotinin), which surgeons say is appropriate in select patients, is nevertheless under the microscope of an FDA advisory committee today regarding safety issues.

The injectable drug, a hemostatic agent used to prevent excessive blood loss during heart surgery brought on by the blood thinner heparin and mechanical tubing used in the heart-bypass machine, has been linked to higher risks of kidney failure and death in several studies conducted over the last couple of years. The FDA is holding the meeting to help determine if such risks can be better clarified, and it could possibly lead to restricted use of the drug.

But two surgeons told this news service that Trasylol is a good option to help restore normal blood clotting in patients at increased risk for bleeding complications because of reversibility problems. These patients, said Dr Robert Higgins at Rush Presbyterian St. Luke’s Medical Center in Illinois and Dr Grayson Wheatley at the Arizona Heart Institute, primarily include those expected to be on the heart-bypass machine for an unusually long time, the elderly, those who have had the surgery before and patients with kidney problems or other medical issues that put them at increased risk for bleeding after surgery.

“Heart surgeons use this medication selectively,” Wheatley said, characterizing about 20% of heart-bypass patients as falling into this higher-risk category. “It’s not something that we give routinely to every patient – there are suitable alternatives – but we do know that Trasylol is the most effective medication for restoring the clotting factors to their normal level in very high risk patients.”

Explaining his endorsement, he said it restores every clotting variable to normal while other drugs only affect some of them, and he added that Trasylol is the quickest acting of such drugs. Those considered less effective are adequate in lower-risk patients, Wheatley said, given their more benign risk-benefit profile than Trasylol. But notably, he said the percentage of higher-risk patients undergoing heart-bypass surgery is on the rise, owing largely to new drug therapies and alternate procedures like stenting that help lower-risk patients avoid the operating room.

“It used to be that the only thing that we used to have was heart surgery,” he said, “but now we only do heart surgery in complex cases or cases in which people don’t respond to other therapies.”

Higgins added that though there are alternatives to Trasylol, he said he prefers to have it as an option.

“In the appropriate patient, the drug has its place,” he said. “Like any other medication, there are risks and benefits to its use, and we as physicians make informed decisions about the risks and benefits and try to come up with a strategy that enhances the patients’ outcome.”

Therefore, neither he nor Wheatley would like to see Trasylol fall under the regulatory guillotine and face a market withdrawal.

“It is not clear, in my knowledge of the information that is out there, that it should be completely removed from the market,” Higgins said. “I think it should be used with caution like any other medication that we use.”

Wheatley, who conceded that Trasylol is not “an irreplaceable medication,” nonetheless cautioned that bypass surgeries would be more complicated for higher-risk patients without it, in terms of added cost, transfusions and follow-up surgeries to drain blood.

It is not yet known whether the FDA will ask its advisors to consider a market withdrawal, as the agency has not publicized specific questions to be pondered. But according to briefing documents released by the FDA, the focus of this event will fall on data from a study not presented at a similar meeting held a year ago.

The agency has indicated that the committee would discuss the strengths and limitations of observational clinical data, especially in light of available controlled clinical data and the overall risks and benefits of Trasylol. Two studies released ahead of last year’s meeting suggested that the drug doubled the risk of kidney failure, and a newer study not discussed at that time showed that Trasylol increased the risk of death by 54%. Yet another study suggested the drug also increased the risk of death by 50% for a certain group of patients.

Bayer, of Germany, has issued statements conceding that the drug appears to be associated with renal dysfunction, but added that its association with kidney failure is not as definitive. Further, the company said data from its global clinical database and a meta-analysis of randomized, controlled trials do not indicate a mortality risk. And lastly, based on the limitations of observational studies, Bayer believes that the reported conclusions are neither valid nor reliable and should not serve as a basis for affecting Trasylol’s use in clinical practice. The drug already has a black box warning.

Ennis & Ennis, P.A. is representing individuals that have been harmed as a result of Trasylol side effects. If you or a loved one have suffered as a result of Trasylol side effects such as kidney failure, heart attack, or stroke you may be entitled to compensation. For more information about a Trasylol lawsuit, a possible Trasylol recall, or for questions regarding Trasylol class action lawsuits click here for a free, confidential case evaluation.