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Women's Health Weekly

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Adverse Drug Reaction



Four reported deaths prompt warning about Mifeprex



August 18th, 2005

The U.S. Food and Drug Administration (FDA) is investigating recently reported serious adverse events associated with mifepristone (trade name Mifeprex, also known as RU-486).

As a result, the FDA is issuing a public health advisory highlighting the risk of sepsis or blood infection when undergoing medical abortion using Mifeprex and misoprostol in a manner that is not consistent with the approved labeling. There are now four cases of deaths from infection from September, 2003 to June, 2005, following medical abortion with these drugs.

"The FDA is committed to sharing emerging drug information with the public and we believe it is important to share...


Source: Women's Health Weekly (2005-08-18)

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