U.S. finally cottons to anti-clotting drug

By ACSH Staff — Mar 23, 2012
Another study has added to the growing evidence that tranexamic acid, a simple generic drug, is the most effective means thus far of slowing bleeding in hemorrhaging trauma patients. Tranexamic acid in pill form (Lysteda) was first approved in the U.S. in 2009 for excessive menstrual bleeding, but it was not widely marketed; as a generic, it was not perceived to be profitable enough to warrant the extensive trials required for FDA approval of its use for trauma patients.

Another study has added to the growing evidence that tranexamic acid, a simple generic drug, is the most effective means thus far of slowing bleeding in hemorrhaging trauma patients. Tranexamic acid in pill form (Lysteda) was first approved in the U.S. in 2009 for excessive menstrual bleeding, but it was not widely marketed; as a generic, it was not perceived to be profitable enough to warrant the extensive trials required for FDA approval of its use for trauma patients. Three promising studies within the last few years, however, along with the British and U.S. armies successful adoption of the drug in 2011, may encourage expansion of its use: Tranexamic acid may soon be appearing in several major medical centers in the U.S.

The drug, which works by promoting blood clotting, has the potential to save 128,000 lives a year 4,000 of them in the U.S. the most recent study of the drug has estimated. The study, published this month in BMC Emergency Medicine, follows close on the heels of research published in 2010 and 2011. The 2010 study found that administration of the clotting drug within three hours of a trauma reduced the risk of fatal hemorrhage by 30 percent; the 2011 study found that severely wounded patients who were given the drug were twice as likely to survive as those who had not received it.

This is no doubt a very useful, lifesaving drug, says ACSH's Dr. Gilbert Ross. It has proved its efficacy in large studies, and there s a serious need for it. Perhaps, based on these newer studies, the FDA will grant approval for its use as an anti-hemorrhage drug for trauma, encouraging greater availability in hospitals nationwide.

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