Local docs ponder use of pulled anti-bleeding drug

- NewsDay

11/07/2007 - Local heart surgeons were unwilling yesterday to dismiss the usefulness of the anti-bleeding drug that was withdrawn from the market earlier this week, though they said they have used it only in rare cases.

"We use it minimally at Long Island Jewish," said Dr. S. Jacob Scheinerman, a cardiac surgeon at the New Hyde Park hospital, referring to the drug Trasylol. "There are other ways to do open heart surgery."

But, Scheinerman said, the hospital still has a supply of Trasylol and he would use it if the situation called for it.

"I would never say never," he said.

The German drug maker Bayer AG voluntarily withdrew the medication from the market at the request of U.S., German and Canadian health agencies after preliminary results from a Canadian study suggested patients using Trasylol had a higher risk of death compared with two other drugs. Heart surgeons use Trasylol to stop excessive bleeding

Dr. Newell Robinson, a cardiac surgeon at St. Francis Hospital in Rosyln, said he has used the medication in "a handful" of cases since its approval by the Food and Drug Administration in 1993 and that it hasn't been used at St. Francis in "well over a year" except in high-risk cases.

Robinson said the hospital's decision to limit the drug's use followed a January 2006 study that found increased risks of kidney failure, stroke, heart attack or heart failure among those who took the drug compared with two other drugs.

Another study published this February found the risk of death rose by close to 50 percent in patients given the drug.

Dr. Tim Gardner, president-elect of the American Heart Association, said there have been concerns about Trasylol's safety for years. "It never has been adopted 100 percent by cardiac surgeons," he said.

However, he said, there are really no other drugs like it. "It is highly effective in certain circumstances," he said.

The drug obstructs the activity of enzymes that dissolve blood clots.

To reduce potential side effects, some surgeons over the years have used it in half doses, Gardner said.

Alternatives to Trasylol include using blood products, such as platelets - sticky particles that help form clots - and surgical techniques that minimize blood loss, the surgeons said.

Two other drugs, aminocaproic acid and tranexamic acid, are also used to help stop excessive bleeding. Robinson said he doesn't use either drug "on a routine basis," in part because no definitive studies have been done to conclude they are as effective as Trasylol.



Q&A

What is Trasylol?

The drug, whose generic name is aprotinin, was approved by the FDA in 1993 to control excessive bleeding during heart surgery.



How widespread is its use?

Trasylol has been used for more than 14 years in more than 4.77 million patients, according to its manufacturer, Bayer AG. In 2006, about 110,000 Americans and about 87,000 patients outside of the United States were given the drug.



How does it work?

It obstructs the activity of enzymes that dissolve blood clots.



What is the problem?

Preliminary findings from a Canadian study suggest it may increase the risk of death.

What are the alternatives?

Blood products such as platelets and surgical techniques that minimize blood loss. Two other drugs, aminocaproic acid and tranexamic acid, are also used.



How important is the drug to Bayer?

Through the third quarter, global revenue for Trasylol was $135 million, including $91 million from the U.S. In 2006 Trasylol was not one of Bayer's top 10 revenue-generating pharmaceutical products, the company 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.