USA. The FDA has advised important new safety changes to the labelling of mifepristone (Mifeprex, RU-486) approved for the termination of early pregnancy. The existing black box on the product label will be updated with new information on the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of mifepristone (Mifeprex, RU- 486). This revision has been proposed following reports of serious bacterial infections, sepsis, bleeding, ectopic pregnancies that had ruptured, and death. The revised labelling will provide physicians and patients with important information so that they can respond and possibly prevent rare but serious complications that may occur with any abortion. The Medication Guide and Patient agreement have also been updated to reflect the new safety information. The FDA will continue to monitor the usage of mifepristone (Mifeprex, RU-486) and may take further action.
FDA Statement, 15 November 2004. Available on the Internet at www.fda.gov