The Abortion Pill:
Is it safe?
RU-486, also known as the Abortion Pill, involves taking two types of abortion pills. These pills will
terminate a pregnancy, and are not the same as what is commonly known as the “morning after pill” or
Plan B, which is designed to prevent pregnancy.
Approved for use with pregnancies within 70 days of the last menstrual period and considered unsafe
beyond that time. The first pill that you will take is mifepristone. It works by blocking progesterone and
causing the lining of the uterus to break down, causing death of the embryo (terminating the
pregnancy). The second is misoprostol (also known as Cytotec). It is taken about 24 to 48 hours after
you take the first pill and causes the uterus to contract and expel the embryo and uterine lining.
We recommend that you have an ultrasound prior to taking the Abortion Pill to determine if the
pregnancy is inside the uterus and how far along you are (see if you are within the 70 days). The
Abortion Pill will not work if you have a tubal or ectopic pregnancy (pregnancy outside the uterus),
which can be dangerous and is a medical emergency.
Women with pre-existing medical conditions may not be eligible to take the Abortion Pill. Women who
cannot receive the Abortion Pill include:
women who are not willing to have an aspiration (surgical abortion) if the pill is not effective.
women with an ectopic pregnancy or mass on their ovaries
women on long-term corticosteroids
women with certain genetic diseases
women who are not able to understand the procedure or how to follow the directions
women who will not have access to emergent medical treatment and facilities
women who have a molar pregnancy, in which the placenta develops abnormally
women who have heart, kidney, or liver problems
women with severe adrenal gland problems
women who currently have an IUD (though you can take the pill upon its removal)
In U.S. trials of RU-486/misoprostol, at least 99% of patients experienced at least one of the following
abortion pill side effects:
Abdominal pain (cramping) (97%)
Back pain (9%)
Uterine hemorrhage (7%)
Viral infections (4%)
“More than one adverse event was reported for most patients. … Approximately 23% of the adverse
events … were judged to be severe.”
“[The] FDA is aware of four women in the United States who died from sepsis (severe illness caused by
infection of the bloodstream) after medical abortion with Mifeprex and misoprostol.”
You may experience a “second wave” of heavy bleeding a few days after passing the pregnancy.
Cramping may increase, along with bleeding and clotting, particularly around the 4 th to 5 th day. If you are
feeling feverish, take your temperature twice daily for 48 hours. It becomes a medical emergency if your
temperature reaches 101.4 degrees F (38.6 degrees C) or higher for more than 12 hours in a row.
During this time, you may:
see large blood clots up to the size of a lemon
feel sick to your stomach
have a mild fever or chills for a little while
have strong cramps
leak a milky nipple discharge (wearing a snug-fitting bra or compression top may help)
After taking the Abortion Pill, wait at least one week to have sex, even if your doctor has prescribed you
antibiotics. This reduces the risk of getting an infection. Also be aware that you can get pregnant very
soon after an abortion.
You should schedule a follow-up appointment with your doctor 4 to 6 weeks after taking the pills to
ensure that the procedure was successful.
National Institute of Health Reports:
Deaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019 https://pubmed.ncbi.nlm.nih.gov/33939340/
Objectives: Primary: Analyze the Adverse Events (AEs) reported to the Food and Drug Administration (FDA) after use of mifepristone as an abortifacient. Secondary: Analyze maternal intent after ongoing pregnancy and investigate hemorrhage after mifepristone alone.
Methods: Adverse Event Reports (AERs) for mifepristone used as an abortifacient, submitted to the FDA from September 2000 to February 2019, were analyzed using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAEv3).
Results: The FDA provided 6158 pages of AERs. Duplicates, non-US, or AERs previously published (Gary, 2006) were excluded. Of the remaining, there were 3197 unique, US-only AERs of which there were 537 (16.80%) with insufficient information to determine clinical severity, leaving 2660 (83.20%) Codable US AERs. (Figure 1). Of these, 20 were Deaths, 529 were Life-threatening, 1957 were Severe, 151 were Moderate, and 3 were Mild.
The deaths included: 9 (45.00%) sepsis, 4 (20.00%) drug toxicity/overdose, 1 (5.00%) ruptured ectopic pregnancy, 1 (5.00%) hemorrhage, 3 (15.00%) possible homicides, 1 (5.00%) suicide, 1 (5.00%) unknown. (Table 1).
Retained products of conception and hemorrhage caused most morbidity. There were 75 ectopic pregnancies, including 26 ruptured ectopics (includes one death).
There were 2243 surgeries including 2146 (95.68%) D&Cs of which only 853 (39.75%) were performed by abortion providers.
Of 452 patients with ongoing pregnancies, 102 (22.57%) chose to keep their baby, 148 (32.74%) had terminations, 1 (0.22%) miscarried, and 201 (44.47%) had unknown outcomes.
Hemorrhage occurred more often in those who took mifepristone and misoprostol (51.44%) than in those who took mifepristone alone (22.41%).
Conclusions: Significant morbidity and mortality have occurred following the use of mifepristone as an abortifacient. A pre-abortion ultrasound should be required to rule out ectopic pregnancy and confirm gestational age. The FDA AER system is inadequate and significantly underestimates the adverse events from mifepristone.
Analysis of severe adverse events related to the use of mifepristone as an abortifacient
Results: The most frequent AERs (Adverse Event Reports) were hemorrhage (n = 237) and infection (66). Hemorrhages included 1 fatal, 42 life threatening, and 168 serious cases; 68 required transfusions. Infections included 7 cases of septic shock (3 fatal, 4 life threatening) and 43 cases requiring parenteral antibiotics. Surgical interventions were required in 513 cases (235 emergent, 278 nonemergent). Emergent cases included 17 ectopic pregnancies (11 ruptured). Second trimester viability was documented in 22 cases (9 lost to follow-up, 13 documented fetal outcome). Of the 13 documented cases, 9 were terminated without comment on fetal morphology, 1 was enrolled in fetal registry, and 3 fetuses were diagnosed with serious malformations, suggesting a malformation rate of 23%.
Conclusions: Hemorrhage and infection are the leading causes of mifepristone-related morbidity and mortality. AERs relied upon by the FDA to monitor mifepristone's postmarketing safety are grossly deficient due to extremely poor quality.