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Patient Information on Mifepristone

Posted January 31, 2008

You may have seen a story in today's New York Times about contaminated leukemia drugs manufactured by the same company that manufactures mifepristone. Mifepristone (also known as RU-486) is used in combination with another medication to terminate an early pregnancy.

It is important to note that mifepristone is manufactured at a different facility than the contaminated leukemia drugs mentioned in the article. According to Danco Laboratories, which distributes mifepristone in the United States, mifepristone is the only drug manufactured at that facility so there is no possibility of cross-contamination from other drugs - as was the case with the leukemia drugs reported on by the Times.

The United States Food and Drug Administration (FDA) regulates manufacturing of all drugs marketed in the U.S. and inspects all facilities where such drugs are manufactured, including those in foreign countries. The Chinese facility where mifepristone is manufactured passed an inspection in May 2007, according to a statement from the FDA. "FDA is not aware of any evidence to suggest the issue that occurred at the leukemia drug facility is linked in any way with the facility that manufactures the mifepristone," the statement said.

Since mifepristone's approval, NAF has educated and trained providers in its use, educated women about the option, and has carefully monitored developments concerning its safety and efficacy. Medical abortion using mifepristone remains a safe and effective way to terminate an early pregnancy, and is widely available in clinics throughout the country. We encourage you to discuss any questions or concerns you may have with your health care provider. You can also obtain unbiased, factual information about abortion and referrals to providers of quality care by calling our toll-free Hotline at 1-800-772-9100. Additional information about mifepristone is available at: http://www.prochoice.org/about_abortion/facts/facts_mifepristone.html.

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