Monday, November 15
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 death which the FDA is referring is not only the fetus' death, but also the risk of death for the mother)
"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 death which the FDA is referring is not only the fetus' death, but also the risk of death for the mother)
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