Bayer's Trasylol Safe in Some Surgeries, Study Says

-Bloomberg

02/08/2008 - Bayer AG's Trasylol, an anti-bleeding drug that was pulled off the market last year, is safe when used during a certain type of cardiac surgery, researchers said.

The drug didn't hold extra risks when given in operations using a pump to maintain blood flow to the heart, doctors said in The Lancet. In surgery without a pump, Trasylol used in combination with the ACE inhibitor class of blood-pressure drugs led to a two-fold increase in kidney dysfunction, a serious complication with a high death-rate, the study said.

``We recorded little association of renal dysfunction in patients undergoing on-pump cardiac surgery, irrespective of ACE use,'' the authors, led by Kai Zacharowski and Ronelle Moulton of Bristol Royal Infirmary, said in the paper.

The test contrasts with previous research that led Bayer to pull Trasylol in November. A study last year linked the product to a 50 percent higher risk of death than competing drugs in patients undergoing heart surgery. A year earlier, data from an analysis of 67,000 patients linked Trasylol to a higher risk of death, kidney failure, congestive heart failure and stroke.

Today's research included 9,875 patients who underwent cardiac surgery between January 2000 and September 2007. In the 848 patients given the drug during off-pump surgery, the presence of an ACE inhibitor was linked to higher kidney dysfunction. The outcomes were compared to patients taking either tranexamic acid or no clotting drug at all, the doctors said.

ACE inhibitors are often used in cardiac surgery to protect the kidneys by reducing blood pressure.

Bayer shares rose 21 cents, or 0.4 percent, to 54.55 euros at 2:19 p.m. in Frankfurt.

Trasylol was first approved by the Food and Drug Administration in 1993. The injectable drug generated 230 million euros ($333 million) in sales in 2005, before revenue fell 34 percent in 2006 on safety concerns stemming from the 67,000- patient analysis.

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.