-NY Times

11/05/2007 - Pressured by drug regulators from around the world, Bayer announced today that it had agreed to withdraw its controversial heart surgery drug Trasylol after a Canadian study found that it may increase the risk of death.

The Food and Drug Administration asked the company to suspend sales of the drug, which is used to stem excessive bleeding during heart surgery, until it has been able to conduct a thorough examination of the full results of the Canadian study.

Two weeks ago, researchers from the Ottawa Health Institute stopped a study of Trasylol because heart surgery patients given the drug had less bleeding but seemed to die at a higher rate than those given two other anti-bleeding drugs.

In a written statement, Bayer said it still believed the drug was beneficial when used as directed.

The Canadian study was the latest in a series of worrisome signs that Trasylol, also known as aprotinin, could be dangerous. Last year, a study published in The New England Journal of Medicine found that the drug increased the risks of kidney failure, heart attack and stroke. The study concluded that halting the drug’s use would prevent 10,000 to 11,000 cases of kidney failure a year and save more than $1 billion a year in dialysis costs.

The F.D.A. convened a panel of experts in September 2006 to review the safety of the drug, and the panel concluded that the drug should remain on the market. But within days of the panel’s meeting, the agency discovered that Bayer had conducted a clinical trial of Trasylol also suggesting that the drug increased the risks of death and stroke but had failed to disclose the results to the F.D.A. or the advisory panel.

Bayer scientists even defended Trasylol at the hearing but did not mention the study or its worrisome results. A company investigation later concluded that the study results were withheld as a result of a “regrettable human error.”

A month ago, the F.D.A. convened the expert panel again and the suppressed study results were disclosed, and it again voted that Trasylol should continue to be sold.

Trasylol’s history demonstrates that once a drug is approved, halting its sales is exceedingly difficult. Experts on advisory panels are often loath to take widely used medicines out of doctors hands, even when their safety is uncertain.

In the interests of speed, the agency often agrees to approve drugs that have not been shown to extend life but have proven effective against interim health measures by, for instance, lowering cholesterol, shrinking tumors or moderating blood sugar levels. In cancer, for instance, the F.D.A. has often assumed that drugs that shrink tumors are likely to extend lives.

But these assumptions sometimes prove false. In the case of Trasylol, the agency assumed that any drug that reduced excessive bleeding during heart surgery would likely benefit patients. Only longer-term trials, however, have been able to demonstrate that the drug, while helpful in bleeding, seems to raise the risks of other, equally serious issues.

Doctors give Trasylol to patients before surgery to reduce the risks of blood loss. It can also reduce the need for transfusions in patients undergoing heart bypass surgery. It works by blocking enzymes that dissolve blood clots.

Bayer said it suspended sales after talking with the F.D.A. and its counterparts in Germany and Canada. Ottawa researchers will need another eight weeks before they have all the study results in hand, Bayer said.

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.