Study warns cardiac patients of risk in widely used drug

- The Australian

02/09/2007 - Patients undergoing cardiac surgery who are given a drug widely used to limit blood loss are almost 50per cent more likely to die than those who do not receive the drug.

Researchers from the Ischemia Research and Education Foundation in San Bruno, California, assessed survival rates at six weeks, six months and annually for five years among patients undergoing coronary artery bypass graft (CABG) surgery at 62 medical centres around the world.

They reviewed the death rates of patients treated with three drugs used to reduce blood loss - aminocaproic acid, tranexamic acid and aprotinin. They also examined the death rate among a control group of 1009 patients who received no anti-bleeding agent.

Over five years, about 20 per cent of the bypass patients who were given aprotinin, sold as Trasylol, died, compared with 16 and 15 per cent for the other two drugs and 12per cent for patients who received no anti-bleeding drugs at all.

Lead researcher Dennis Mangano said doctors should use the other drugs rather than Trasylol.

"These other drugs can be used in 95 per cent of patients," Dr Mangano said. "Maybe for 5 per cent, surgeons can consider Trasylol. But this study means they now have to talk to the patient and get informed consent. They need to say that some studies show an increased risk, but if we get into trouble during surgery I'd like to use it."

Lynne Pressley, a cardiologist at the Royal Prince Alfred Hospital in Sydney, said Trasylol was the subject of several new trials after a study last year suggested the drug could double a patient's likelihood of developing kidney failure.

"There is currently under way in Canada a large multi-centre trial comparing aminocaproic acid, tranexamic acid and aprotinin and we're all awaiting those results," she said.

"Doctors are cautious and I think they are using it only for the high-risk patients and not universally.

"But a lot of people have been using this drug over the last 10 years and we haven't seen a corresponding increase in the complication rates."

Bayer Pharmaceuticals, the maker of aprotinin, yesterday issued a statement saying the study, published in the Journal of the American Medical Association, was flawed.

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.