Side effects of mifepristone

What Happens to Your Body in the Hours and Days After an Abortion

One in three women in Britain will have an abortion at some point in their lives, but if it hasn’t happened to you, you might not know much about the actual process. Outdated horror stories involving iron forceps still loom large in the public consciousness, when the majority of abortions today begin with taking a pill.

There are two main types of abortion: medical (using pills to induce a miscarriage) and surgical (where the pregnancy is removed during a minor operation). Exactly what happens and how long it takes varies from woman to woman, and, obviously, depends on how far into the pregnancy you are. But if you’re going for a medical abortion, here’s a rough idea of what you can expect to happen during the 72 hours afterwards.

First up, it’s important to know that a medical abortion happens in two stages, using two different types of medication. If you’re less than ten weeks pregnant, these can be taken on the same day, but more commonly you’ll return to the clinic for a second appointment, one to two days after the first one.

Hour 1: At your first appointment, you’ll take the abortion pill Mifepristone, which works by blocking the hormone progesterone. Without progesterone, your body can’t continue the pregnancy and the lining of your uterus (AKA the endometrium) begins to break down. Mifepristone also works by making your uterus more sensitive to the second abortion pill, Misoprostol.

Then, depending on your individual circumstances, you’ll either go home straight away, or you’ll stay at the clinic to take the second round of medication. If you’re under ten weeks pregnant and take the second pill on the same day, most clinics recommend that you get a lift home afterwards, as the bleeding can start quite quickly in early pregnancy – not something you want happening on the bus.

Hour 1 to Hour 24: Assuming you’re taking the abortion pills over two separate appointments, you’ll probably find that not a lot happens during the first 24 hours after Mifepristone. You might get a bit of bleeding, nausea and period-type cramping, but basically, you should be fine to carry on with life as normal.

“Quite often there are no symptoms at all, and women panic; they’ll ring you up and say, ‘Nothing’s happened.’ That’s OK; you don’t necessarily feel anything particularly after you have the first tablet,” explains Dr Kate Guthrie, a Consultant Gynaecologist and spokesperson for the Royal College of Obstetricians and Gynaecologists. However, if you’re sick within an hour of taking Mifepristone, you should let the clinic know as soon as possible.

It’s pretty unlikely that Mifepristone by itself will cause you to miscarry, but if you’re in early pregnancy (i.e. less than ten weeks) and experience heavy bleeding between your two appointments, tell the clinic so they can check it out.

WATCH: Drone Delivered Abortion Pills and the Fight for Reproductive Rights

Hour 24 to Hour 26: Again, this varies from person to person, but after one or two days you’ll return to the clinic for your second appointment. The second pill is called Misoprostol and – rather than swallowing it – is placed either in your vagina, or between your gum and your cheek, where it dissolves for quicker absorption.

Hour 26 to Hour 28: Misoprostol causes your womb to contract, basically mimicking a miscarriage. Bleeding and cramping usually start around two hours after taking Misoprostol, but it’s different for everyone.

Hour 28 to Hour 30: The contents of your pregnancy typically make their way out of your vagina in the form of clots and tissue around four to six hours after taking Misoprostol. You’ll stay in the clinic during this entire time, with a toilet or bedpan on hand to bleed into.

You don’t have to look at what’s coming out, but it’s important to be aware that, the further along in your pregnancy you are, the more likely you are to see something that’s recognisably a foetus. At ten weeks, the foetus is about the size of a large grape, whereas, at 24 weeks, you’re looking at something the size of a small melon.

While the foetal tissue is passing, you’ll get very heavy bleeding and cramping, which, according to Dr Guthrie, is “usually worse than period pain, but not as bad as labour pain”. If you’ve had a miscarriage before, that’s the kind of pain level to expect. You’ll be given painkillers before it gets too bad, and the nurses will be keeping an eye on what comes out to make sure you’ve passed the foetus and the afterbirth.

It can take longer than six hours, particularly with later term pregnancies. As a general rule – and for obvious reasons – the more developed the foetus, the harder the uterus has to work to expel the pregnancy. If it takes a particularly long time, you may also be given extra doses of Misoprostol every few hours, to help the abortion along.

Hour 30 to Hour 72: For most women, the abortion will be complete within 12 to 24 hours of taking Misoprostol, and the heavy bleeding will then start to calm down. At this point, your newly emptied womb cramps down, nipping shut the blood vessels that supply your uterine lining, and replacing the heavy bleeding with a light ooze. This usually happens quite quickly – between 30 minutes and a couple of hours afterwards – but some women will continue to bleed heavily for up to 48 hours.

You’ll probably have some light bleeding and cramping for a few days afterwards, and you may also get symptoms like sore breasts, diarrhoea and nausea – but these should be fairly short-lived.

72 hours+: The bleeding can last up to three to four weeks, on and off, but should get lighter and lighter each day, going from a light bleed to a pink or brown discharge. You can carry on taking painkillers for any pain or discomfort, and it’s best to use pads rather than tampons for the first few weeks.

In fact, says Dr Guthrie, don’t put anything in your vagina until the bleeding has stopped, just to reduce the risk of infection – no tampons, no fingers, no pensises, or anything else!

You’ll also be fertile again much quicker than you might expect, so most clinics will chat to you about contraception before you leave, and make sure you’re kitted out with condoms, the pill or your contraceptive of choice.

If you notice anything weird in the days and weeks after an abortion, get in touch with the clinic to have it checked out. Complications are pretty rare, but warning signs to look out for include large clots, unusual smells and pain suddenly getting worse. Most clinics will give you a 24-hour helpline number to call if you’re concerned.

For more information and advice on abortion and family planning, contact the British Pregnancy Advisory Service (BPAS https://www.bpas.org/)

the organization

Mifepristone alone usually does not cause any side effects before taking Misoprostol, although some women may experience light bleeding or nausea.
After using Misoprostol you should expect bleeding and cramps. Bleeding usually starts within four hours of using the pills, but it sometimes starts later.
For some women, the bleeding and cramping and also other side effects like nausea, vomiting, diarrhea, headache, dizziness, and hot flashes or fever may occur shortly after taking Misoprostol.
Bleeding is often the first sign that the abortion has begun. If the abortion continues, bleeding and cramps become more severe. Bleeding is often heavier than a normal menstruation, and there can be clots. The longer the pregnancy has developed, the heavier the cramps and the bleeding will be. If the abortion is complete, the bleeding and the cramps diminish. The moment of abortion can be noticed with a peak of heavier blood loss and more pain and cramps.

Normally the bleeding will continue lightly for one to three weeks after the abortion, but times may vary. The normal menstrual period usually returns after four to six weeks.

The heaviest bleeding typically occurs 2-5 hours after using misoprostol and usually slows down within 24 hours. The most intense cramping and bleeding generally lasts for 3-5 hours, but it can last for less or more time. Some women bleed heavily for up to 48 hours and may pass clots days or even weeks after taking the misoprostol. This is common and is not dangerous, unless you soak through more than two maxi pads per hour for 2 hours or more or when you lose heavy cloths bigger than an orange. It is normal for your body to take time to empty the uterus completely. Every woman’s body is different.

Abortion Pill

The name Abortion Pill is most commonly used to reference the medications mifepristone and misoprostol taken to terminate the pregnancy of a developing baby.

Some individuals confuse the morning after pill or emergency contraception with the abortion pill. The two are not the same.

Methotrexate is another abortion-related medication possibly referred to as the abortion pill. In either of these inquiries, individuals asking about this medication are considering terminating their pregnancy.

If you are experiencing an unplanned pregnancy, you are not alone! Asking questions about the abortion pill is important to ensure you have all the information you need to know about your options. You can also ask questions about the medical, possible physical and emotional side effects of abortion, the abortion pill itself, and what resources are available to help you if you decide to keep your baby, give it up for adoption or continue with the termination of pregnancy.

Got questions? We have answers. Call the helpline now: 1-800-672-2296

When should the abortion pill be taken?

The abortion pill is approved by the FDA for use to terminate a pregnancy during the first 10 weeks after your last menstrual period. This means that the abortion pill may be taken up to 70 days or a little over 2 months after the first day of your last period.

If you are more than 10 weeks pregnant and considering an abortion, you will need to look at surgical abortion procedure options because the embryo is too developed for these medications to terminate completely.

How effective is the abortion pill?

The abortion pill is fairly effective, failing about 2% to 8% of the time. The earlier in your pregnancy, the more likely it is to be successful with termination. The higher 8% failure rate is associated with taking abortion medications later in your pregnancy and possibly outside the intended approval period.

Approximately 2 to 4 individuals out of a 100 will discover a failed abortion attempt with a continuation of their pregnancy. You have options: consider carrying the baby to term and parenting yourself or choosing the baby’s parents via adoption; or returning to the clinic for a second attempt at a medical abortion or more than likely, a surgical option.

Learn more about the abortion laws according to your state.

How much does the abortion pill cost?

The financial cost ranges from approximately $300 up to around $800. Factors that affect the cost of abortion include:

  • Lab work
  • Office visit
  • Types of testing
  • Region of country

If the abortion pill fails and your pregnancy continues, you will have to pay for a second abortion procedure.

How does the abortion pill work?

The first step is to discuss your options, learn about resources available to you, and learn about medical abortion in more detail. From there, you will go through a medical exam which includes the following:

  • Medical history
  • Lab work
  • Physical exam

Following the medical exam, you will be asked to sign a liability release. Your abortion provider should give you a guide that explains the medication and termination process. The three-step abortion pill process includes the following:

  1. Take Mifepristone: A medication used to block the activity of progesterone. Progesterone is one of your pregnancy hormones that is necessary for the uterus’ ability to support a pregnancy. Mifepristone blocks the ability of your body’s progesterone to be recognized by the uterus, causing the lining of the uterus to break down and ending the life of the developing embryo. If you change your mind about the abortion and decide to carry the baby to term, you may reverse the effects of Mifepristone with the Abortion Pill Reversal protocol.
  2. Take Misoprostol: This medication is taken to cause the uterus to contract and expel the embryo, embryonic sac, and lining of the uterus, expelling the developing baby. This process usually takes 24-48 hours and is often accompanied by heavy bleeding and strong uterine cramping.
  3. Return to Clinic: You will need to come back to the clinic for an exam 2 weeks later to confirm if the medical abortion was completely successful or not. *This is a very important step because if the abortion was not complete, any parts left behind could cause an infection and leave permanent effects.

How long does it take for the abortion to complete?

The second pill, Misoprostol, is taken 24 to 48 hours after the first pill, Mifepristone, is taken. Approximately half will experience the heavy cramping and bleeding necessary to expel the embryo, uterus lining, and embryonic sac within the first five hours. The majority of women will complete the expulsion within a few days.

Your abortion provider will usually encourage you to watch the toilet for passing the blood and embryo tissue. Your provider will also schedule a time for a return visit to make sure that abortion is final.

This appointment usually occurs between 1 to 2 weeks after initiating the abortion process, but it could be as many as three weeks.

What should you expect during the medical abortion process?

Once you take the second regimen, Misoprostol, you should plan to experience heavy bleeding, cramping, and possibly other symptoms.

Although it is possible to experience some light bleeding before taking the second medication, the majority of heavy bleeding and cramping occurs after the second pill. Other symptoms or side effects you may experience include the following:

  • Dizziness
  • Intense cramping
  • Nausea (with or without vomiting)
  • Diarrhea
  • Abdominal pain separate from cramping
  • Mild fever or chills
  • Light lactation

The bleeding should mimic a very heavy period. You may notice blood clots and bodily tissue passing as well. Avoid using a tampon during this process and for a short time after termination. It is best to use overnight pads to absorb the blood and tissue that is expelled.

You should begin to feel better the next day, and continue to improve each of the next few days, unless you happen to be the percentage of women that experience adverse effects from the abortion attempt. If you experience any of the physical risks below, contact your healthcare provider immediately.

What are the risks of the abortion pill?

Like any procedure or medication, there are risks related to the abortion pill. Although rare, an incomplete abortion is a risk, which may lead to a second procedure with additional side effects.

Other medical abortion risks include:

  • An allergic reaction
  • Infection
  • Blood clots
  • Heavier bleeding than expected
  • A continued pregnancy

Although extremely rare, severe reactions to the medication can be fatal. An infection or ectopic pregnancy may be severe and even life-threatening. The abortion pill does NOT end or treat an ectopic pregnancy.

A Finland study found an association between abortion and elevated mortality rates. Therefore, it is imperative that you contact your abortion provider if you experience any of the following:

  • Excessive bleeding that fills up more than two pads in an hour and occurs for two hours or more.
  • Blood clots that occur for two hours or more
  • A fever of 100.4°F or higher
  • Nausea (with or without vomiting) for more than 24 hours
  • Diarrhea for more than 24 hours
  • Foul smelling discharge
  • Pregnancy symptoms
  • Extreme depression or suicidal thoughts

When should my period return?

Once the pregnancy is terminated, it is considered the end of a menstrual cycle. You should expect to have your period return within the next two months. It is rare for a period to be absent longer than two months.

Aftercare following the abortion procedure

It is important for you to consult with your healthcare provider on an after abortion care treatment plan. Most will advise that you wait at least a week before engaging in sexual intercourse. This might get extended to two weeks depending on your circumstances.

If it was an unplanned pregnancy, you might need to think about abstaining from sexual intercourse again until you are ready for the outcome of the reproduction process. It is possible to experience ovulation and get pregnant again within the first month. Conception is possible if you engage in sex again, even during the first couple of weeks.

Cautions for those considering taking the abortion pill

Abortion is a personal choice, and like all medical and surgical procedures, it has side effects.

You should take caution before taking the abortion pill if:

  • You are past the 10-week window
  • You believe it is taking a baby’s life
  • You are morally opposed to abortion
  • Someone is forcing you to choose abortion
  • You will refuse a surgical abortion if the medication fails
  • You are taking blood clotting medication
  • You have a blood clotting condition
  • You are using an IUD
  • You are emotionally unstable or have depression or anxiety

Emotional challenges are more likely for those who believe they are terminating a life. It is important that you talk with a professional in regards to your beliefs around getting an abortion.

What about Getting Pregnant in the Future?

Mifepristone and Misoprostol are not considered harmful to future fertility, according to the Food and Drug Administration or FDA. However, the long-term effects of these drugs have not been studied as extensively as the surgical procedures.

More Helpful Articles:

  • Abortion Pill Reversal
  • Abortion Follow Up Care
  • My Three Pregnancy Choices

Compiled using information from the following Sources:

1. Basu, Ranjan, et al., Mifepristone and Misoprostol for Medical Termination of Pregnancy: the effectiveness of a Flexible Regimen, Journal of Family Planning and Reproductive Health Care 29(3),(2003).

2. Grimes, David, “Risks of Mifepristone Abortion in Context, Contraception 71 (2005)

3. Hausknecht, R., “Mifepristone and Misoprostol for Early Medical Abortion: 18 months Experience in the United States, Contraception 61,(2003)

4. Misoprostol.org, Adverse Effects: Potential Problems with Misoprostol, Retrieved Dec 2016.

5. Planned Parenthood, “The Abortion Pill”, Retrieved Dec 2016.

6. ParkMed NYC, “Abortion By Pill Process, Retrieved Dec 2016.

Mifepristone

Before receiving this medicine, you must read a Mifeprex Medication Guide. Then, you must sign a Patient Agreement form stating that you understand the risks and benefits of using this medicine.

Complete treatment to end the pregnancy will require at least 2 visits to your doctor.

  • At the first visit (Day 1) you will be given a Mifeprex tablet. You will also be given or prescribed 4 misoprostol tablets. If you receive only a prescription for misoprostol, be sure to get the prescription filled right away so you will be ready to take the medicine on schedule.
  • In 24 to 48 hours, you will take 4 misoprostol tablets at one time. For treatment to be effective, you must take misoprostol 24 to 48 hours after you took Mifeprex.
  • Misoprostol can cause cramps, nausea, diarrhea, and other side effects. Your doctor may give you medicine to treat or prevent these side effects.
  • Your uterus should begin to pass the pregnancy within 2 to 24 hours after taking misoprostol. Be sure you are in a place where you will be ready for this to happen. You will likely have fairly heavy vaginal bleeding while your uterus is passing the pregnancy.
  • At the second visit (Day 7 to 14 after you took Mifeprex), your doctor will check your uterus to make sure the pregnancy has completely ended.
  • If your body has not completely passed the pregnancy, you may be given another dose of misoprostol. If you take a second dose of misoprostol, you should have a follow-up visit 7 days later.

Cramping and bleeding are signs that this medicine is working properly. But sometimes you can have cramping and bleeding and still be pregnant. Only your doctor can confirm whether your pregnancy has completely ended. Using a home pregnancy test kit is not effective in confirming that your uterus has been completely cleared of the pregnancy. Do not miss any of your follow-up visits.

You may need surgery to end the pregnancy completely. Carrying a pregnancy to term after taking Mifeprex or misoprostol may cause birth defects or death of the baby. Talk with your doctor about your treatment options.

Bleeding and spotting are normal side effects of Mifeprex and misoprostol. It is possible to continue bleeding for up to 30 days. Bleeding may be heavier than a normal heavy period, and you may also pass blood clots and tissue.

Call your doctor if you bleed enough to soak through 2 full-size sanitary pads per hour for 2 hours in a row. In rare cases, serious and sometimes fatal bleeding or infection may occur after termination of a pregnancy. Call your doctor if you have heavy vaginal bleeding or a general ill feeling. You may also have a fever, stomach pain, or fast heartbeats.

Go to an emergency room if you still have any of the following symptoms more than 24 hours after taking misoprostol: fever, severe stomach pain, heavy or prolonged vaginal bleeding, nausea, vomiting, diarrhea, or feeling like you might pass out. Be sure to tell your caregivers when you last took misoprostol.

It is possible to get pregnant again right after terminating a pregnancy. You may begin using birth control after your doctor has confirmed that treatment with Mifeprex has effectively ended your pregnancy.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Since Mifeprex is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Since Mifeprex is used as a single dose, it does not have a daily dosing schedule.

Call your doctor for instructions if you miss any follow-up appointment.

Copyright 1996-2020 Cerner Multum, Inc.

Latest Update: 11/9/2018, Version: 6.01

Mifepristone (Mifeprex)

Before taking mifepristone,

  • tell your doctor if you are allergic to mifepristone (hives, rash, itching, swelling of the face, eyes, mouth, throat, hands; difficulty breathing or swallowing); misoprostol (Cytotec, in Arthrotec); other prostaglandins such as alprostadil (Caverject, Edex, Muse, others), carboprost tromethamine (Hemabate), dinoprostone (Cervidil, Prepidil, Prostin E2), epoprostenol (Flolan, Veletri), latanoprost (Xalatan), treprostinil (Orenitram, Remodulin, Tyvaso);any other medications, or any of the ingredients in mifepristone tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor if you are taking corticosteroids such as beclomethasone (Beconase, QNASL, QVAR), betamethasone (Celestone), budesonide (Entocort, Pulmicort, Uceris), cortisone, dexamethasone, fludrocortisone, flunisolide (Aerospan HFA), fluticasone (Advair, Flovent, Veramyst, others), hydrocortisone (Cortef, Solu-Cortef, U-Cort, others), methylprednisolone (Medrol, Depo-Medrol), prednisolone (Omnipred, Prelone, others), prednisone (Rayos), and triamcinolone (Kenalog, others). Your doctor will probably tell you not to take mifepristone.
  • tell your doctor what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: benzodiazepines such as alprazolam (Xanax), diazepam (Diastat, Valium), midazolam, or triazolam (Halcion); buspirone; calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Cartia, Diltzac, others), felodipine, nifedipine (Adalat, Afeditab CR, Procardia), nisoldipine (Sular), or verapamil (Calan, Verelan, in Tarka); carbamazepine (Equetro, Tegretol, Teril, others); chlorpheniramine (antihistamine in cough and cold products); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet), lovastatin (Altoprev, in Advicor), or simvastatin (Simcor, Zocor, in Vytorin); clarithromycin (Biaxin, in Prevpac); cyclosporine (Gengraf, Neoral, Sandimmune); erythromycin (E.E.S., Erythrocin, others); haloperidol; furosemide; HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, others), or saquinavir (Invirase); itraconazole (Onmel, Sporanox); ketoconazole (Nizoral); methadone (Dolophine, Methadose); nefazodone; phenobarbital; phenytoin (Dilantin, Phenytek); pimozide (Orap); propranolol (Hemangeol, Inderal, Innopran); quinidine (in Nuedexta); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); rifabutin (Mycobutin); tacrolimus (Astagraf, Prograf, Protopic, others); tamoxifen (Soltamox); trazodone; or vincristine (Marqibo Kit). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially St. John’s wort.
  • tell your doctor if you have or have ever had an ectopic pregnancy (‘tubal pregnancy’ or pregnancy outside the uterus), adrenal failure (problems with your adrenal glands), or porphyria (an inherited blood disease that may cause skin or nervous system problems). Your doctor will probably tell you not to take mifepristone. Also, tell your doctor if you have had an intrauterine device (IUD) inserted. It must be removed before you take mifepristone.
  • you should know that it is possible that mifepristone will not end your pregnancy. Your doctor will check to be sure that your pregnancy has ended when you return for your follow-up appointment after you take mifepristone. If you are still pregnant after taking mifepristone, there is a chance that your baby may be born with birth defects. If your pregnancy has not ended completely, your doctor will discuss other options to consider. You may choose to wait, take another dose of misoprostol or have surgery to end the pregnancy. If you take a repeat dose of misoprostol, you must have a follow-up visit with your doctor in 7 days after that dose to be sure that your pregnancy has ended.
  • tell your doctor if you are breastfeeding.

  • if you are having surgery, including dental surgery, tell the doctor or dentist that you have taken mifepristone.
  • you should know that after ending a pregnancy with mifepristone, you can become pregnant again right away, even before your period returns. If you do not want to become pregnant again, you should begin using birth control as soon as this pregnancy ends or before you start having sexual intercourse again.

Updated 4/12/2019

  1. What is Mifeprex and how does it work?

    Mifeprex (mifepristone) is a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue. Mifeprex, when used together with another medicine called misoprostol, is used to end an early pregnancy (70 days or less since the first day of the last menstrual period).

  2. Is there a generic version of Mifeprex?

    The FDA approved GenBioPro, Inc.’s abbreviated new drug application (ANDA) for generic Mifeprex on April 11, 2019. This approval reflects FDA’s determination that GenBioPro’s product, Mifepristone Tablets, 200 mg, is therapeutically equivalent to Mifeprex and can be safely substituted for Mifeprex. Like Mifeprex, the approved generic product is indicated for the medical termination of intrauterine pregnancy through 70 days gestation.

  3. Who should not take Mifeprex?

    Some women should not take Mifeprex. A woman should not take Mifeprex if it has been more than 70 days since the first day of her last menstrual period, or if she:

    • has an ectopic pregnancy (a pregnancy outside of the uterus)
    • has problems with the adrenal glands (the glands near the kidneys)
    • is currently being treated with long-term corticosteroid therapy (medications)
    • has had an allergic reaction to mifepristone, misoprostol or similar drugs
    • has bleeding problems or is taking anticoagulant (blood thinning) drug products
    • has inherited porphyria
    • has an intrauterine device (IUD) in place (it must be removed before taking Mifeprex).

    This information applies equally to the approved generic version of Mifeprex.

  4. What changes to the Mifeprex application did the FDA approve on March 29, 2016?

    The FDA first approved Mifeprex in 2000. In 2016, the agency approved a supplemental application submitted by the drug company that markets Mifeprex. This approval included changes in the dose of Mifeprex and the dosing regimen for taking Mifeprex and misoprostol (including the dose of misoprostol and a change in the route of misoprostol administration from oral to buccal (in the cheek pouch), the interval between taking Mifeprex and misoprostol, and the location at which the woman may take misoprostol). The approval also modified the gestational age up to which Mifeprex has been shown to be safe and effective, as well as the process for follow-up after administration of the drug. In addition, the labeling was revised to meet the current labeling requirements in the FDA’s regulations. The FDA also approved changes to the existing Risk Evaluation and Mitigation Strategy (REMS) to reflect the changes approved in the supplemental application, and to make the Mifeprex REMS consistent with more recently approved REMS.

    Find approval information for this supplement here.
    Find more information here: Mifeprex (mifepristone) Information

    Of note, on April 11, 2019, FDA approved a supplemental application for Mifeprex, approving modifications to the existing approved REMS for Mifeprex to establish a single, shared system REMS for mifepristone products (including Mifeprex as well as the approved generic version of Mifeprex) for the medical termination of intrauterine pregnancy through 70 days gestation. In establishing the single, shared system REMS, no changes were made to the substantive elements of the REMS. This single, shared system REMS is known as the Mifepristone REMS Program.

    Find approval information for this 2019 supplement here.

    The approved generic version of Mifeprex generally has the same labeling as Mifeprex. As discussed below (see question 7), the approved generic version of Mifeprex is required to use the single, shared system REMS with the brand product, Mifeprex.

  5. Where can women get Mifeprex?

    Mifeprex is supplied directly to healthcare providers who meet certain qualifications. It is only available to be dispensed in certain healthcare settings, specifically, clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber. It is not available in retail pharmacies, and it is not legally available over the Internet. These requirements also apply to the approved generic version of Mifeprex.

  6. What qualifications must healthcare providers have to obtain and dispense Mifeprex?

    Healthcare providers who would like to become certified to prescribe Mifeprex must have the ability to date pregnancies accurately and to diagnose ectopic pregnancies. Healthcare providers must also be able to provide any necessary surgical intervention, or have made arrangements for others to provide for such care. Healthcare providers must be able to ensure that women have access to medical facilities for emergency care, and must agree to other responsibilities, including reviewing and signing the Patient Agreement Form with the patient and providing each patient with a copy of the signed Patient Agreement Form and the Medication Guide.

    Healthcare providers who prescribe and who meet certain qualifications are authorized to order and dispense Mifeprex. Some states allow healthcare providers other than physicians to prescribe medications. Healthcare providers should check their individual state laws.

    These requirements also apply to the approved generic version of Mifeprex.

  7. Are there restrictions on the distribution of Mifeprex?

    When the agency reviewed and approved the original new drug application for Mifeprex in 2000, it concluded that certain distribution restrictions were necessary to ensure the safe use of that drug. These restrictions were converted to a risk evaluation and mitigation strategy (REMS) in 2011. In 2016, after reviewing the additional data and information submitted by the sponsor of Mifeprex, and after taking into consideration the safety data that had become available since the initial approval of Mifeprex, the FDA concluded that certain restrictions continue to be necessary to ensure the safe use of Mifeprex.

    These restrictions also apply to the approved generic version of Mifeprex. Under the law, the approved generic version of Mifeprex is required to use a single, shared system REMS with the brand product, Mifeprex. This single, shared system REMS, known as the Mifepristone REMS Program, sets forth the distribution requirements that must be followed for both Mifeprex and the approved generic version of Mifeprex.

    Under the Mifepristone REMS Program, Mifeprex and the approved generic version of Mifeprex may only be supplied directly to healthcare providers who are certified to prescribe the drug product and who meet certain qualifications. Under this REMS, the products are only available to be dispensed in certain healthcare settings, specifically, clinics, medical offices and hospitals, by or under the supervision of a certified prescriber. They are not available in retail pharmacies and are not legally available over the Internet. The FDA warns consumers they should not buy Mifeprex or GenBioPro, Inc.’s approved generic version of Mifeprex, Mifepristone Tablets, 200 mg., over the Internet because they will bypass important safeguards designed to protect their health.

  8. What are the possible side effects of using Mifeprex?

    Cramping and vaginal bleeding are expected effects of the treatment regimen. In some cases very heavy vaginal bleeding will need to be stopped by a surgical procedure, which can often be performed in a healthcare provider’s office. Other common side effects of the treatment regimen include nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness in the first day or two after taking the two medicines.

    The possible side effects are described in the Adverse Reactions section of the labeling and in the Medication Guide for Mifeprex.

    This information applies equally to the approved generic version of Mifeprex, which generally has the same labeling as Mifeprex.

  9. What serious adverse events have been reported after Mifeprex use?

    It is not uncommon for the FDA to receive reports of serious adverse events for prescription drugs after they are approved. The FDA has received reports of serious adverse events in women who took Mifeprex. As of December 31, 2018, there were reports of 24 deaths of women associated with Mifeprex since the product was approved in September 2000, including two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal. The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient. A summary report of adverse events that reflects data through December 31, 2018 is here. The FDA has reviewed this information and did not identify any new safety signals. The FDA intends to update this summary report on an annual basis or as appropriate.

    As with all approved drugs, when the FDA receives new information regarding adverse events, the agency reviews the new information and, as appropriate, takes necessary action, including providing updates to healthcare providers and their patients so that they have information on how to use the drug safely.

  10. What should healthcare providers watch for in women who have taken Mifeprex?

    All providers of medical abortion and emergency room healthcare practitioners should investigate the possibility of sepsis in women who are undergoing medical abortion and present with nausea, vomiting, or diarrhea and weakness with or without abdominal pain. These symptoms, even without a fever, may indicate a serious infection. Strong consideration should be given to obtaining a complete blood count in these patients. Significant leukocytosis with a marked left shift and hemoconcentration may be indicative of sepsis. This information applies equally to Mifeprex and the approved generic version of Mifeprex.

  11. Is it possible for a woman to become pregnant again if she takes Mifeprex?

    It is possible for a woman to become pregnant again soon after a pregnancy ends. If a woman who has terminated a pregnancy does not want to become pregnant again, she should start taking appropriate precautions after the pregnancy ends. A woman should consult with her healthcare provider regarding any specific questions she may have. This information applies equally to Mifeprex and the approved generic version of Mifeprex.

  12. Is Mifeprex approved in any other countries?

    Mifepristone for termination of pregnancy has been approved in France since 1988, and also is approved in the United Kingdom, Sweden, and approximately 60 other countries.

  13. How much does Mifeprex cost?

    The FDA does not have the authority to regulate the prices of drug products in the United States. Manufacturers, distributors, and retailers establish the prices. Additionally, the FDA has no input into or legal control over whether an insurance company does or does not cover the cost of a drug. Insurance coverage is a decision made by an insurance provider. This information applies equally to Mifeprex and the approved generic version of Mifeprex.

The pills fail completely in about 1 percent of the women. They remain pregnant and surgical abortions are urged because the pills can cause birth defects.

While mifepristone is a new drug in the United States, the second drug, misoprostol, is not. It is sold by Searle, a division of the Pharmacia Corporation, under the name Cytotec, and is approved as a treatment for ulcers. Because doctors can legally prescribe any approved drug for any purpose, it does not require a separate approval by the health agency for use in abortions.

Claudia Kovitz, a spokeswoman for Searle, said that the company did not test it for use in abortions and would not promote it for that application. Ms. Kovitz said that the drug carried a warning stating it was not to be used in pregnancy.

The Food and Drug Administration placed several restrictions on the use of mifepristone. Women may only use the drug for abortions within the first seven weeks after their last menstrual period (a third of all abortions in the United States now take place within this time); doctors providing the abortion pills must be able to accurately determine the duration of a pregnancy and to diagnose a tubal pregnancy, which cannot be terminated with the drugs; and doctors must also be able to perform a surgical abortion should one prove necessary or have another doctor available who can do so.

In addition, doctors dispensing the drugs must report any pregnancies that are not terminated after women take the medications and must report any serious events, like hospitalizations and blood transfusions, to the drug’s sponsor, the Population Council, which has agreed to study the drug after it goes on the market.

The Abortion Pill:
Medical Abortion with Mifepristone and Misoprostol

What is the Medical Abortion?

Medical Abortion (brand name Mifeprex) is a form of early abortion caused by the combination of two medications, mifepristone and misoprostol that is an option for women who are 8 weeks pregnant or less. Also known as RU486 or medication abortion.

During the first appointment at the clinic you receive the mifepristone pill to take orally. Then 24 to 72 hours later, in the privacy of your own home, you take the the second medication, misoprostol. Misoprostol causes contractions resulting in a miscarriage. When used in combination, mifepristone and misoprostol are 95-97% effective within two weeks. Mifepristone and misoprostol are FDA approved.

How Does It Work?

Mifepristone blocks the hormone progesterone needed to maintain the pregnancy. Because this hormone is blocked, the uterine lining begins to shed, the cervix begins to soften and bleeding may occur. With the later addition of the second medication, misoprostol, the uterus contracts and the pregnancy is usually expelled within 6 to 8 hours.

Because the woman chooses when she takes the second medication within the time frame of 24 to 72 hours after the first medication, she has some control over the timing of when she expels the pregnancy and experiences the side effects of bleeding and cramping. Some women choose the Medical Abortion because of the privacy it offers. Some women feel empowered by taking an active role in the process.

Use

At your first appointment at the clinic, an ultrasound is performed to confirm you are less than 8 weeks pregnant. You then speak with an experienced counselor who explains how mifepristone and misoprostol work and makes sure you get answers to all of your questions. Your health history is carefully reviewed and if you meet the criteria, the doctor will give you the mifepristone to take orally. You are also given one bottle containing four tablets of misoprostol to be used 24 to 72 hours after taking mifepristone. If this first dosage fails to induce a miscarriage, please call the clinic to receive instructions on using your back-up misoprostol tablets.

What To Expect

Upon taking mifepristone at the clinic you may begin to bleed. As each woman’s body is different, bleeding varies from woman to woman. Some may experience light bleeding much like spotting towards the end of a menstrual period. Others have heavier bleeding like their regular menstrual period, or like a heavy period. Some women do not experience any bleeding until taking the misoprostol.

Upon taking the second medication misoprostol tablet, cramping, bleeding, and clotting may begin as soon as 20 minutes. Within the next 6 to 8 hours, most women will miscarry. Cramping may come in waves with increasing and decreasing intensity. You can expect bleeding heavier than a menstrual period with large clots. During this time, you will pass the embryo although you may not see it since it is very small. The amount of bleeding when using the Medical Abortion is greater than with aspiration abortion.

Aftercare

A follow-up exam is scheduled for two weeks later to make sure the process is complete. If you have not yet miscarried, we will perform a aspiration abortion. A very small percentage (5%) of women do not pass the pregnancy tissue and need a suction procedure to complete the process.

Side Effects

Most of the side effects when using this early abortion option are caused by the second medication, misoprostol. Side-effects may include heavy bleeding, headache, nausea, vomiting, diarrhea, and heavy cramping.
Risks

Vaginal bleeding with medical abortion could be extremely heavy. In rare situations it could require a aspiration abortion and very rarely, a blood transfusion. You will be given our 24-hour hotline number to call if you have any problems. Medical staff are on call at all times to answer your medical questions and concerns.

If pregnancy is continued after taking these medications, there is a high risk of fetal deformities.

Criteria

Abortion Medication may be an option if you:

  • Are less than 8 weeks since your last menstrual period.
  • Are willing and able to give informed consent.
  • Have the support you need such as access to reliable transportation and ability to communicate with the clinic by telephone.
  • Live no more than 2 hours away from emergency medical care (a hospital).
  • Are able to come back to the clinic for 1 to 3 follow-up appointments.
  • Agree to have a surgical abortion if the misoprostol does not induce termination.

Your Health

Due to the risk of serious health problems, mifepristone and misoprostol may not be recommended if you:

  • Have had a blood clotting problem or are taking anticoagulant medicine.
  • Have severe anemia.
  • Have adrenal failure.
  • Are taking long-term systemic corticosteroids.
  • May have an ectopic pregnancy.
  • Have a mass in the tubes or ovaries.
  • Have inherited porphyria.
  • Have an allergy to mifepristone, misoprostol or other prostaglandin medicine.
  • Have severe diarrhea.

Future Fertility

According to studies of the FDA (Food and Drug Administration) and the National Abortion Federation, there are no known long term risks associated with using mifepristone and misoprostol. Therefore, women may pursue another pregnancy whenever they feel the time is right after having a Medical Abortion.

Other Options For Early Abortion

If you are at least 6 weeks by ultrasound, you can choose to have a surgical abortion, in which the cervix is dilated and suction aspiration is used to remove the tiny pregnancy.

No Confusion

Do not confuse Medical Abortion with the “Morning After” Emergency Contraception Pills (brand name Plan B). They are completely different medications taken for different purposes.

  • Emergency Contraception Plan B contains the same hormones as in regular birth control pills; Plan B prevents pregnancy after sex when taken within days after unprotected intercourse. Emergency Contraception will not harm an existing pregnancy. You can get Plan B Emergency Contraception at your local pharmacy. You don’t need a prescription if you are 17 or older. If you are under 17 you need a prescription but in Washington State you can get the prescription right at the pharmacy: call ahead to check if they have a trained prescriber on shift.
  • The Abortion Pill Mifeprex is ONLY sold to physicians. (You cannot get it at a pharmacy in the USA.) A physician or nurse-practition will first make sure that you are pregnant, that you want an abortion, that you understand how to take care of yourself and what to expect during the medical abortion, and then will give you the Abortion Pill which causes the pregnancy to end.

more:

  • Comparison of Medical and Surgical Abortion
  • 10 Facts You Must Know about Non-Surgical Abortion – published by AlterNet
  • On Their Own Terms – by Anna Quindlen
  • www.womenonweb.org – will mail medications to women in countries where abortion is legally restricted (run by Rebecca Gomperts of Women on Waves)
  • Gynuity – http://www.gynuity.org/ – Instructions for Use of Misoprostol for Women’s Health in Arabic, English, French, Portuguese, Russian and Spanish
  • www.medicationabortion.com – In English, French, Spanish and Arabic – a multi-language website provides accurate information about medication abortion to health service providers including physicians, nurse practitioners, physician assistants, counselors, and office staff as well as educational information for women considering the option of medication abortion. Sponsored by Ibis.
  • Feminist Majority Foundation’s info on RU 486.
  • UCSF – University of CA at San Francisco patient education page – medical vs surgical abortion

last update: October 19, 2010

The life of a fetus cannot be separated from the life of the pregnant woman. This is unique in medicine and law. No one can create a set of medical principles or legal principles giving a right to life to the fetus, because by doing so, inevitably the woman’s rights become limited.

Feminist Women’s Health Center

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