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KEYCODE BAYER #286

January 26, 2007

Deadly Side Effects: Bayer ends 3 Trasylol clinical studies

German drugmaker Bayer said on Thursday it has stopped three studies to expand the use of its heart-surgery drug Trasylol, sending its shares down as much as 2.6 percent. Bayer had expected peak sales of more than 500 million euros ($649.4 million) for the drug.

Bayer said in a statement the move followed new guidelines for Trasylol, requiring the drug to be administered in surgical settings where a heart-lung machine is available. "The use of cardiopulmonary bypass (CPB) is not practical in non-cardiac surgical settings," the company said.

The studies were to investigate the safety and effectiveness of Trasylol on transfusion requirements and blood loss in spinal fusion surgery and two types of cancer surgeries. The decision also came after U.S. health officials warned last month that the drug could increase the risk of kidney damage and more precautions might be needed in the future. The Food and Drug Administration also said the drug will come with a stronger warning about possibly fatal allergic reactions, or anaphylaxis.

Patients should not receive Trasylol if they have already been given the drug within the past year, it said.

Trasylol has been at the centre of an FDA safety review since two published studies linked the drug's use to kidney problems earlier this year. The drug, approved in 1993, is also known as aprotinin bovine. It aims to reduce bleeding and the need for blood transfusions in heart surgery patients. (By Mantik Kusjanto)

Feb 7, 2007

Drug to slow bleeding leads to more deaths: study

A drug used to limit blood loss while patients undergo coronary-artery bypass surgery also carries a higher five-year risk of death than cheaper generic alternatives, a researcher said on Tuesday.
Based on five years of data on 3,876 heart bypass patients from around the world, the death rate among the 1,072 patients given Bayer AG's drug aprotinin was nearly 21 percent, two-thirds higher than the mortality rate among surgery patients not given anti-bleeding drugs.
In coronary-artery surgery, a clogged artery that normally feeds the heart is bypassed with a section of vein or artery transplanted from the patient's leg or from elsewhere.
Many heart patients are given a blood thinner upon arriving at the hospital, while aprotinin administered during surgery would cause blood to clot.
"These patients have come to the hospital because they have vessels that are clotted," said study author Dr. Dennis Mangano of the Ischemia Research and Education Foundation, based in San Bruno, California.
"Isn't there a subset of patients that might be adversely affected by a drug which, though it mitigates bleeding, promotes clotting? And we found that there was," Mangano said in a telephone interview.
A majority of the deaths in the study, which was published in this week's Journal of the American Medical Association, were caused by heart attacks, heart failure, strokes or kidney failure. Mangano said clots started by the drug likely build up over time and block arteries, starving organs of oxygen.
But Bayer AG, which makes aprotinin under the brand name Traysol, responded in a statement that Mangano's analysis was faulty in part because the drug is usually given to the sickest patients more likely to die if they bleed excessively.
"Generally, sicker patients who were already at greater risk for mortality were treated with aprotinin," Bayer said.
Mangano said he had extensive data on the patients and controlled for how sick they were at the start of the study.
An editorial accompanying the study showed how important, and how rare, it is to fully monitor drugs after they gain regulatory approval.
The drug has been administered to 4 million patients worldwide since 1985, including 600,000 in 2005, at a cost of up to $1,500 a patient.
The study found the death rate following aprotinin use was 1 percent higher each year following surgery compared to two generic anti-bleeding alternatives. The alternatives, which belong to a different class of drugs, cost between $11 and $44 per patient though some surgeons believe they do not work as well, Mangano said.
A year ago, he published a study saying patients given aprotinin was more likely to suffer kidney failure within a few days to a month after surgery. He said the report depressed sales of the drug by 37 percent.
Depending on the response from surgeons, "I would not be surprised if (aprotinin) use drops fairly substantially over the next couple of years or sooner," he said. By Andrew Stern

more information:
NYT article "Bayer failed to report risks of drug"
Trasylol: Bayer Drug Shows Flaw in Studying Safety
Bayer drug Trasylol carries tougher kidney warning - FDA
Bayer´s Trasylol: Multiple Risks of Surgery Drug Seen