Drug Warning: Mifeprex

Generic name: mifepristone (known as the “abortion pill”)

Manufactured and marketed by: Danco Laboratories

Purpose: Designed for women in order to end a pregnancy during its early stage without surgery, in a process sometimes called a drug-induced or medical abortion.

Side Effects Reported

  • Mifeprex works by blocking a hormone called progesterone, that is required to sustain a pregnancy.
  • Blocking the progesterone hormone causes the uterine lining to break down. Mifeprex is used in conjunction with another drug called misoprostol, which is taken after Mifeprex to assist in the termination of the pregnancy.
  • Misoprostol is designed to trigger contractions of the uterus, which expels the embryo.

Industry Report

The FDA has added a black box warning to the labeling of Mifeprex concerning harmful side effects including severe bleeding and sepsis. Mifeprex has been linked to reports of sepsis in women who have used the drug, along with misoprostol, to end a pregnancy. Sepsis, or septic shock, can occur when there is a bacterial infection in the bloodstream that may affect vital organs and has the potential to be fatal if not properly treated. Some reports indicate that Mifeprex has been linked to at least 4 deaths from sepsis in the United States alone. There is an additional report indicating the death of a woman in Canada from sepsis as well. The four women who died in the United States all suffered infections from the same rare bacteria known as Clostridium sordellii.

Seeger Weiss is not currently pursuing lawsuits on this drug, but its drug warnings will remain on our radar.

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