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Abortion drug's off-label use may have led to deaths
Date:6/16/2008

Preliminary U-M studies indicate that oral use of RU-486's companion drug misoprostol is safe, but vaginal use may undermine body's immune responses

The off-label use of a drug given with RU-486 to terminate a pregnancy may be responsible for a handful of rare, fatal infections seen in women taking the drugs since 2000, a study by University of Michigan scientists suggests.

The drug misoprostol is FDA-approved to be taken by mouth along with RU-486 to end a pregnancy. But many women have received the drug vaginally as part of the two-drug combination, a method of delivery not evaluated by the FDA.

In animal and cell culture studies, the U-M researchers found that misoprostol, when given directly in the reproductive tract, suppresses key immune responses and can allow a normally non-threatening bacterium, Clostridium sordellii, to gain the upper hand and cause deadly infection. When absorbed through the stomach, however, the drug did not compromise immune defenses or cause illness.

The study, which appears today online ahead of print in the Journal of Immunology, also has implications for understanding dangerous infections that occur during pregnancy.

"Infections after medication abortions are rare, and Clostridium infections after abortion are exceedingly rare," says David Aronoff, M.D., an infectious disease specialist who led the U-M study.

The results provide evidence why doctors should avoid giving misoprostol vaginally and underscore the wisdom of giving it by mouth instead, says Aronoff, an assistant professor in the Department of Internal Medicine at the U-M Medical School. "The findings should help make a safe procedure even safer."

Context: More than a half-million women in the United States have undergone medication abortions safely using the two drugs since the FDA approved the method in 2000.

The new study suggests that Planned Parenthood decided wise
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Contact: Anne Rueter
arueter@umich.edu
734-764-2220
University of Michigan Health System
Source:Eurekalert  

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