What it is
- RU-486 is an artificial steroid that blocks progesterone, a hormone needed to continue a pregnancy. Mifipristone is the generic name. It is sold in the US under brand names Mifeprex® and Early Option.®
- It is usually used in combination with Misoprostol (brand name Cytotec®) a type of prostaglandin.
When it is Used
- FDA has recently (March 2016) approved RU486 to be used within 10 weeks (70 days) after the first day of last menstrual period. However, after 7 weeks the risk of complications increases.
How it works
- Mifepristone blocks the hormone, progesterone, causing the lining of the uterus to break down, making it unable to sustain the life of the growing fetus.
- Misoprostol, given two days after Mifepristone, causes cramping and significant bleeding causing the uterine lining and the fetus to be expelled. Passage of blood clots and tissue is to be expected.
What to expect
- The FDA-approved regimen for medical abortion in the State of Texas requires three doctor’s office visits.On your first office visit, your ultrasound should be able to demonstrate that you have a viable, progressing, intrauterine pregnancy. This is confirmed only when a fetal pole (measurement from tip of head to bottom of rump) can be measured and a fetal heart rate is detected on sonogram/ultrasound. If this cannot be confirmed, the procedure may not be necessary because 15% to 20% of all pregnancies end in miscarriage.  (Lifestyle factors, such as smoking, alcohol and illegal drugs increase the risk of miscarriage.) Most occur within the first 13 weeks of pregnancy. It is also imperative that ectopic pregnancy (fetus growing outside the uterus, usually in a fallopian tube) is ruled out, as that is a life threatening condition for the mother, and the abortion pill will not work to abort ectopic pregnancies.
- Mifipristone (RU486) is given more than 24 hours after the sonogram at your second office visit. FDA has recently changed the protocol so that you may take the second medication, Misoprostol 24 to 48 hoursafter the Mefipristone is taken, droping the requirement of an office visit, where you could be assessed for complications. The final doctor’s office visit takes place 7 to14 days after receiving the medication, to determine if the abortion has been complete. It is essential that you keep each appointment so that the medical staff can assess for potential life threatening complications, such as infection and hemorrhage.
- Before you begin a medication abortion, you will be given a Medication Guide, and will be required to sign a consent, stating that you fully understand the possible risks and complications of the medications.
- Some bleeding may start after receiving the first drug, Mifepristone, but you should expect it to be heavy with clots and potentially severe cramping after taking the second drug, Misoprostol. Bleeding or spotting can be expected for an average of 9-16 days and may last up to 30 days. Note thatbleeding and cramping is not proof of complete expulsion of all products of pregnancy. That is why it is essential for you to return to your provider 7-14 days after.
- Medical abortion is not 100% effective. 5% -8% of women will need a surgical procedure to end pregnancy or stop excessive bleeding.
Possible side effects
In U.S. trials of RU-486/misoprostol, at least 99% of patients experienced at least one of the following:
- abdominal pain (cramping) (97%)
- nausea (67%)
- headache (32%)
- vomiting (34%)
- diarrhea (23%)
- dizziness (12%)
- fatigue (9%)
- back pain (9%)
- uterine hemorrhage (7%)
- fever (4%)
- viral infections (4%)
- vaginitis (4%)
- rigors (chills/shaking) (3%)
“Approximately 23% of the adverse events…were judged to be severe.” Because side effects will likely be experienced while not under direct supervision of medical personnel, make sure you have ready access to emergency medical attention. Possible emotional trauma of expelling the fetus must also be taken into consideration.
Risks from a failed or incomplete abortion (8% of chemical abortions): Infection and uncontrolled bleedingleading to possible maternal death, as well as birth defects if abortion fails.
If you have pain 3-5 weeks after abortion, seek immediate medical attention to rule out an undetected ectopic pregnancy (a life threatening condition).
Important things to consider before choosing a medical abortion:
- Beware: There is much misinformation about the Abortion Pill on the Internet. Never order this medication on the internet. There is no regulation so you don’t know what you are getting.
- What is called the “Mexican Abortion Pill” may cause severe cramping, but may be ineffective in ending a pregnancy.
- RU-486 was approved by the FDA under a special “restricted distribution” approval process known as “Subpart H,” reserved only for drugs that treat “severe or life-threatening illnesses”, such as AIDS or Cancer.  This accelerated approval process, along with pregnancy being lumped together with life-threatening illnesses, raises many unanswered questions, particularly of whether standards for safety may have been unnecessarily compromised. However, Subpart H allows the FDA to retain the right to oversee the drug’s use after approval, and the right to pull the drug if it proves too dangerous or the manufacturer allows the drug to be used improperly.
- New more lenient protocol from the FDA (March 2016) allowing the abortion pill to be given as late as 10 weeks after the first day of last menstrual period, as well as their dropping the required office visit before the Misoprostol may lead to increased undetected complications.
- Cytotec (brand name for Misoprostol, the drug used with RU486) has been reported to cause the uterus to rupture (tear) when given after the eighth week of pregnancy. Rupture (tearing) of the uterus can result in severe bleeding, hysterectomy, and/or maternal or fetal death.” 
- “The clinical trials in the FDA excluded patients younger than 18 years old. FDA labeling states that the safety and efficacy in this age group have not been studied.”
- No long term studies have been done to determine the long term effects of an RU486 abortion.
- Misoprostol, used in the medical abortion regimen with RU 486, is a drug indicated for the use of preventing gastric ulcers which may be a side effect when people take NSAID medications, like aspirin. It has not been approved by the US Food and Drug Administration (FDA) for abortion or other obstetric or gynecologic use. “Although it has not been approved by the US Food and Drug Administration (FDA) for this use, in 2002, pregnancy was removed from the label as an absolute contraindication to misoprostol use.” There has not been a separate approval and labeling of misoprostol for this use (medical abortion).”
- RU486 is manufactured exclusively in China, and distributed by Danco, a company established for the sole purpose of selling its only product. Questions must be raised concerning the ability of Danco and FDA to monitor the production process for safety standards. It also raises questions of how to get legal action in the case of injury or death.
- The 2016 FDA-approved regimen for medical abortion is as follows:
- On Day One: 200 mg of Mifeprex taken by mouth.
- 24 to 48 hours after taking Mifeprex: 800 mcg of misoprostol taken buccally (in the cheek pouch), at a location appropriate for the patient
- About seven to fourteen days after taking Mifeprex: follow-up with the healthcare provider
- FDA is aware that many medical practitioners use modified regimens, which may include prescribing different doses of mifepristone and misoprostol, dosing misoprostol on a different day, and/or advising patients that the misoprostol tablets be inserted into the vagina. While some of the modified regimens have been described in the medical literature, the safety and effectiveness of mifepristone and misoprostol dosing regimens other than the one in currently approved labeling have not been evaluated by FDA.
- “In November 2002, the black box warning was revised and strengthened to add new information on the risk of serious bacterial infections, sepsis, bleeding, and death that may occur following any termination of pregnancy, including use of Mifeprex. In July 2005, FDA approved a labeling supplement to again strengthen the black box warning on the product by noting that ‘atypical presentations of serious infection…can occur without fever, bacteria or significant findings on pelvic exam…” And to advise patients to seek immediate medical attention if they experience prolonged heavy bleeding.”
- “FDA is aware of 12 deaths possibly involving the use of mifepristone in women. Nine of these deaths were in the U.S. Of these, five were determined to be related to infections, one involved an undiagnosed ectopic pregnancy, one appears unlikely to be related to the use of mifepristone, one was determined to be unrelated to either the medical abortion or the use of mifepristone and misoprostol.” The last is currently under investigation.
- Medical abortion is costly because the actual RU486 pills are expensive, and because the regimen requires 3 office visits.
Do not take RU486/Mifepristone if:
- It has been more than 70 days (10 weeks) since your last menstrual period began.
- You have an IUD. It must be taken out before you take RU 486.
- Your provider has told you that you have a pregnancy outside the uterus (ectopic pregnancy).
- You have problems with your adrenal glands (chronic adrenal failure).
- You take a medicine to thin your blood.
- You have a bleeding problem.
- You take certain steroid medicines.
- You cannot return for the follow-up visits.
- You cannot easily get emergency medical help in the 2 weeks after you take Mifeprex.
- You are allergic to mifepristone, misoprostol, or medicines that contain misoprostol, such as Cytotec or Arthrotec.
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