RU-486 / Mifeprex

Modified on 2009/10/14 21:32 by admin
RU-486, also known as Mifepristone, Mifeprex or the "abortion pill," is a drug given during early pregnancy to terminate the pregnancy without the need for a conventional suction abortion. The drug can be administered up to forty-nine days after the last period begins.

Well over 500,000 women have used RU-486 to date. The drug, first approved in France over ten years ago, is distributed in the United States by Danco Laboratories. Some abortion opponents have questioned the safety of RU-486, particularly its relatively rare propensity to cause severe bleeding. In November 2004, Danco Laboratories and FDA notified healthcare professionals of revisions to the BOXED WARNING and WARNINGS sections, the MEDICATION GUIDE and PATIENT AGREEMENT of the Prescribing Information to describe serious and sometimes fatal infections and bleeding that may occur following the use of Mifeprex. In July 2005, Danco Laboratories and FDA revised the BOXED WARNING and WARNINGS sections of the Prescribing Information, the Medication Guide and Patient Agreement to inform healthcare professionals of four cases of septic deaths in the United States, all reported from California, from September 2003 to June 2005 in women following medical abortion with mifepristone (Mifeprex) and misoprostol. The bacteria causing sepsis has been identified in two of the cases as Clostridium sordellii. The two confirmed cases of Clostridium sordellii did not have the usual signs and symptoms of an infection.

See Also

  1. Pregnancy & Female Reproduction Drugs: Overview
  2. Excessive Bleeding: Overview
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