Public Health Advisory Issued for Mifepristone and Risk of Sepsis

July 20, 2005

July 19, 2005 -- ROCKVILLE, MD -- The 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 today 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 with healthcare providers and patients the latest serious reports of infection associated with this drug that we have received," said Dr. Steven Galson, Acting Director of FDA's Center for Drug Evaluation and Research.

The bacteria thought to have caused the fatal infection have been identified in two of the cases and the other two cases are under investigation by FDA along with the Centers for Disease Control and Prevention, State and local health departments, and the manufacturer of Mifeprex. Doctors are urged to have a higher level of suspicion for sepsis in their patients taking Mifeprex.

Previously, the FDA has received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death. Those reports led to the revision of the black box labeling. Mifeprex was approved by the FDA in 2000.

For more information, please go to https://www.fda.gov/cder/drug/infopage/mifepristone/default.htm.

Source: The Food and Drug Administration