posted on Nov, 16 2004 @ 07:20 AM
FDA To Announce Important Labeling Changes for Mifepristone
"The Food and Drug Administration will announce today important new safety changes to the Danco Laboratories, LLC's labeling of mifepristone (trade
name Mifeprex, also known as RU-486). Mifeprex was approved in 2000 for the termination of early pregnancy, defined as 49 days or less. FDA and Danco
Laboratories have received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death, including another
death from sepsis that was recently reported to FDA. These reports have led to the revision of the black box labeling.
The new warnings to health care providers and consumers include changes to the existing black box on the product to add 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 Mifeprex. While
these risks are rare, the new labeling and Medication Guide will provide the latest available information to all.
The new information reminds health care providers that serious bacterial infection and sepsis may occur without the usual signs of infection, such as
fever and tenderness on examination. Health care providers should be aware that prolonged, heavy bleeding may warrant surgical interventions. The
label also warns that health care providers should be vigilant for patients with undiagnosed ectopic pregnancies (tubal pregancies) as this condition
may be missed by physicial examination and ultrasound. Some of the symptoms of an ectopic pregnancy may mimic the expected symptoms of a medical
termination of pregnancy. Mifepristone is not effective for termination of these pregnancies."