Using the Chemical Abortion Pill Off-label Results in Higher Complication Rates
March 20, 2013
In 2000, the Food and Drug Administration (FDA) approved the chemical abortion pill, often called RU-486 or Mifeprex, for U.S. use. Like other prescription drugs, the FDA issued important health and safety information for its use.
The FDA gives a specific timeframe for using Mifeprex:
Mifeprex is used, together with another medication called misoprostol, to end an early pregnancy (within 49 days of the start of a woman’s last menstrual period).
However, abortion providers are using Mifeprex well-past 49 days of pregnancy. Here’s what the National Abortion Federation and Planned Parenthood say on their websites:
National Abortion Federation:
Depending on the prescribing physician’s protocols, mifepristone and misoprostol can be used for early abortion up to 63 days after the start of the last menstrual period.
The abortion pill is a medicine that ends an early pregnancy. In general, it can be used up to 63 days — 9 weeks — after the first day of a woman’s last period.
Using a drug “off-label,” or outside of the FDA guidelines isn’t illegal. But, of course it carries risks.
Results of an American clinical trial for chemical abortion were published in the New England Journal of Medicine. Researchers found that Mifeprex had a:
- Failure rate of 8% of pregnancies at 49 days
- Failure rate of 17% of pregnancies at 56 days
- Failure rate of 23% of pregnancies at 63 days
This means that when abortions are done up to 63 days – like Planned Parenthood does – nearly 1 in 4 women have to return to the abortion facility because parts of the baby’s baby and/or supportive tissue remain in the uterus, which can quickly lead to infection. Because of this high complication rate, abortion facilities need to have health and safety standards in place to take care of women returning to their facility.
If a woman returns with an incomplete abortion or side effects of Mifeprex – ongoing vaginal bleeding, diarrhea, nausea, or vomiting – the facility needs to care for the woman and be accessible in the unfortunate case of medical emergency.
Senate Bill 371, a bill that passed the Indiana Senate in February and is now before the Indiana House, addresses the health and safety standards necessary for caring for a woman who is ill because of Mifeprex. It requires abortion centers have sterile instruments, appropriately credentialed staff and clean facilities. If the woman’s condition can’t be taken care at the facility and an ambulance needs to be called, then the facility has to have hallways wide enough to accommodate emergency crews and their equipment for transporting the woman.
SB 371 ensures women’s health won’t be jeopardized by a facility that simply isn’t up to par. And because abortion providers are doing chemical abortions at a point in pregnancies where 23% of women have complications, abortion facilities need to be ready to care for them with common sense health and safety standards that we expect in Indiana.