Public Health Advisory for Mifepristone

The FDA is investigating recently reported serious adverse events associated with Mifeprex (mifepristone), also known as RU-486. As a result, the PDA has issued a public health advisory highlighting the risk of sepsis, or blood infection, when undergoing a 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 after a medical abortion with these drugs.

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 the FDA, along with the Centers for Disease Control and Prevention, state and local health departments, and Danco Laboratories LLC, the manufacturer of Mifeprex. Doctors are urged to have a higher level of suspicion for sepsis in their patients taking Mifeprex.

Previously, the FDA had 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 for Mifeprex, approved by the FDA in 2000. The drug is approved as part of a regimen that calls for at least three visits to a doctor’s office or clinic, according to the labeling. On the first visit, the woman receives counseling and a medication guide. Then she takes 600 milligrams of mifepristone by mouth while at the doctor’s office. Two days later, she returns to the physician and, if she is still pregnant, takes 400 micrograms of misoprostol by mouth while in the doctor’s office. Misoprostol, a prostaglandin, causes the uterine muscles to contract and end the pregnancy.

“The FDA is committed to sharing emerging drug information with the public and we believe it is important to share with health care providers and patients the latest serious reports of infection associated with this drug that we have received,” says Steven Galson, M.D., Director of the FDA’s Center for Drug Evaluation and Research.

Visit www.fda.gov/cder/drug/infopage/ mifepristone for more information.

Copyright Superintendent of Documents Sep/Oct 2005