When Birth Control Fails

FDA-Approved Use of Mifeprex (RU-486)

July 16, 2018

On September 28, 2000, the Food and Drug Administration (FDA) announced the approval of RU-486. The controversial medication that is frequently referred to as the”abortion pill.” It’s prescribed in the United States from the brand name Mifeprex (mifepristone).

The drug had previously been applied in Europe and it was immediately adopted in the USA. After its approval, the entire number of abortions dropped by more than a quarter million per year from 2001 to 2011.

The number of surgical abortions declined dramatically while the amount of medicated abortions climbed to constitute almost a quarter of their total.

FDA Changes in 2016 for Mifeprex

The clinical expertise of the security of cured abortion prompted changes into the FDA-approved program in 2016 that lets it be utilized through 70 days of gestation and do not require in-person visits for its dosage of misoprostol and post-treatment evaluation. The original FDA tag was for use up to 49 days of gestation, which made it an alternative for 37% of abortion patients. The 70-day window causes it to be an option for 75% of abortion patients. The 2016 guidelines also expand who can prescribe the drug.

How Mifeprex is Offered

The rules for RU-486 (Mifeprex) required three visits to a physician’s office while the revised guidelines require only a couple of visits. The drug can only be prescribed by a doctor after a human chorionic gonadotropin (HCG) test, which measures the amount of a hormone produced in the body during pregnancy.

Doctors also should execute a sonogram to date and confirm the pregnancy. The 2016 guidelines allow the medicine to be utilized for up to 70 days of gestation (10 months ).

Once pregnancy has been confirmed, you’ll be given two kinds of medicine. To begin with, you’ll be given one dose of mifepristone, which will make it impossible for a fertilized egg to remain connected to the lining of the uterus.

Originally, the dose was tablets, but this was reduced to a single tablet, taken orally.

The second drug, misoprostol, triggers uterine contractions and is taken two weeks later. The new guidelines allow it to be administered in the home as four pills you place in your cheek instead of consuming, letting them dissolve for half an hour. The initial guidelines, enforced by a few states, required one to drop by your physician to take this second medicine.

Misoprostol terminates pregnancy anywhere from six hours to one week later. You must be prepared for cramping and bleeding, which may continue for many days.

Your health care provider must assess your condition seven to 14 days after taking mifepristone. The FDA no longer specifies that this must be an on-the-go trip. If the pregnancy is still present, a surgical abortion must be carried out.

Potential side effects of RU-486 include uterine cramps, nausea, fatigue, and significant bleeding. Most women recover completely in a few hours per week. The success rate for cured abortion is 92 percent to 92.5% during the first seven months of pregnancy. This leaves a small percentage of girls who may require additional surgery.

Should you suspect you might be pregnant and you also would like to use the abortion pill to terminate your pregnancy, you need to contact your physician or an area practice as soon as possible to discuss your alternatives.

Advantages and Disadvantages

The two main advantages of a medicated conclusion of a pregnancy would be its high rate of effectiveness and that it is much less intrusive and painful than a surgical abortion.

In terms of the disadvantages, Mifeprex might not be an alternative for women with liver or kidney problems, diabetes, nausea, or even people who are overweight. It may not work if combined with other drugs. Side effects can include minor cramping, nausea, vomiting, diarrhea, and bleeding which lasts eight to ten days.

Changes to the FDA guidelines represented the practice by many doctors. But some countries had passed legislation requiring strict adherence to the FDA tagging instead of the enlarged off-label use.

The shift of the labeling may expand entry to some treated abortion.