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Published: Friday, 6/18/2010

Drug shows promise to stop fatal bleeding

BLADE NEWS SERVICES

LONDON - A generic drug that costs less than $10 a treatment may save as many as 100,000 lives a year by preventing people from bleeding to death after accidents, researchers said.

The medicine, tranexamic acid, is now used to control bleeding in hemophiliacs, after surgery, and by women who have abnormally heavy menstrual periods. It had never been studied for accident victims.

The drug, given in two injections to patients bleeding after accidents, slashed deaths 10 percent compared with a placebo, a study published this week in the journal Lancet found. The medicine reduced deaths from bleeding 15 percent, without significant adverse effects, according to the research that covered more than 20,000 patients from 40 countries.

"It's probably one of the cheapest ways to save a life there ever was," said Ian Roberts, the lead researcher from the London School of Hygiene & Tropical Medicine, at a news conference in London. "The treatment is seriously cheap. It doesn't get much more effective than this."

Doctors had worried that use of TXA on accident victims might raise side effects such as blood clots in the heart and lungs, strokes, or heart attacks. The study found no such evidence, though the authors said they could have missed some incidents.

TXA is off-patent and manufactured generically by many firm. The study was funded by the National Institute for Health Research, based in London. Pfizer Inc., which sells a version under the brand name Cyklokapron, provided the tranexamic acid from its plant in Sandwich, England. Pfizer, the world's largest pharmaceutical company, is based in New York.

The researchers asked the World Health Organization in Geneva to categorize the drug as an essential medicine, on a shopping list many countries use to determine which products to buy, Mr. Roberts said. The product costs about $4 a dose, with one given as an immediate injection and the second delivered intravenously over an eight-hour period.

In the study, 14.5 percent of patients given tranexamic acid died within four weeks of treatment, compared with 16 percent for the placebo. About 4.9 percent given the drug died from bleeding, compared with 5.7 percent for placebo.

For people between 5 and 45, accidents are the world's second leading cause of death after AIDS. About 600,000 injured patients bleed to death every year.



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