There have been some horrendous stories linked to Trasylol, which has long been used during cardiac surgery to stem blood loss in those patients prone to bleeding.
In one case, a Long Island woman launched an $80 million lawsuit against Bayer AG after her husband's health took a dramatic downward turn following surgery with Trasylol. Suffering only from a mild heart murmur prior to surgery, the 52-year-old travel agent underwent surgery for a heart valve repair and bypass in mid-January of 2006.
Less than 7 months later, Joseph Randone would be dead. Not long after surgery, his kidneys shut down, and he required dialysis. His legs had to be amputated after gangrene set in. At the time of his death on August 8th of that year, the man was hooked up to feeding and breathing tubes.His surgeon filed a report with the FDA, and vowed never to use Trasylol again.
Meanwhile a woman identified only as Tonya writes in a kidney blog that her father was given Trasylol after his heart bypass surgery, "and now has kidney failure requiring dialysis three days a week.
"He NEVER had kidney problems before being given this drug."
Trasylol was given a new lease on life by the FDA on September 21st, 2006 when an FDA panel reviewed all available safety information on Trasylol and, while cautious, concluded that the benefits outweighed the risks. As much as the FDA has been accused of protecting the interests of drug companies in deference to public health, the FDA could be forgiven for being led down the garden path when a Bayer safety study slamming Trasylol for risk of kidney damage, congestive heart failure, stroke, and death—was revealed a week AFTER the FDA panel re-affirmed Trasylol.
Bayer AG noted that the oversight was a result of regrettable human error, and two employees were reprimanded.
The halted BART study in October served to add further fuel to the Trasylol fire. For now, the drug is off the market, although Bayer states the claw back is a temporary measure pending analysis of the Canadian study data. And the FDA has said it may still make Trasylol available to surgeons, on a case-by-case basis.
There is little doubt that there has been little good news about Trasylol in the last two years.
However, aprotinin—which is what Trasylol is—has been around for a long time. And up until January of 2006, it was hard to find anything negative about Trasylol.
Incredibly, a story that ran in the January 2, 2006 edition of the Washington Post suggested that aprotinin was being studied to death. Reference was made to 18 years of research and trials. One study, in fact, studied the various studies.
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The study concluded that "this advantage was clear by June 1992, after the 12th of 64 studies" conducted on aprotinin.
In other words, back off. Aprotinin is safe.
That was January 2nd, 2006. Less than three weeks later, the New York Times revealed yet another new study, at the time about to be published in the New England Journal of Medicine, suggesting that aprotinin had the potential to increase the risk for kidney failure, heart attacks and strokes. Aprotinin, it was suggested, "should be abandoned."
From friend to foe, in fewer than three weeks.
The question remains, if Trasylol (aprotinin) carried so much risk, how could such risk manage to be overlooked over a period of 18 years?
We may never know.