From email alert today by the American Association of Pro-life Obstetricians and Gynecologists:
The regulations surrounding the use of Mifeprex [RU-486] are worse than awful: There is voluntary reporting of severe adverse events to the manufacturer, Danco Labs, who then decides which events are severe enough to report to the FDA. Is that bizarre, or what? A drug whose purpose and action is to kill intrauterine tissue is given to young pregnant women, and the follow up is at the discretion of the “doctor” who gives it.
Bizarre! Why not mandatory follow up and mandatory adverse events reporting? Tissue is being killed, may or may not exit the uterus, may or may not involve infection, and there is no required reporting.
This is midevil medicine, a “medical coathanger.” No one knows
what the real “severe adverse events” frequency is – because no one in medical officialdom wants to know badly enough to raise an outcry.
This kind of medical care for young women absolutely stinks. AAPLOG, CMDA, AND CWA have a pending petition to the FDA asking for suspension of Mifeprex approval and review of the flawed
approval process. Consideration of the petition continues to be stonewalled by the FDA. We keep on pushing.
All four sepsis deaths [of RU-486 since 2003] were from California, so obviously no other state is using the medicine. You bet!