"I feel that it is my obligation to tell my story for all the women out there that have been fooled that this so called “natural way of abortion” is in no way normal."

"As a matter of fact it was a freakish nightmare for me!"

INTRODUCTION: ISIS' STORY AND INTERVIEW

Tucked inside a historic downtown Brooklyn building, The Best Women's Medical Care (BWMC) clinic, also known by its website as "The Women's Choice", provides gynecological and abortion services. As a reproductive health care clinic for women, BWMC claims to educate, inform and provide clinical and emotional security for their valued patients.

On April 11, 2013, Isis, a 22-year-old college student from New York had an appointment with BWMC's staff  to obtain counseling and guidance, so she could make an informed health care decision, about terminating her early unplanned pregnancy.

After receiving her sonogram, it was determined that Isis was 5 weeks and 4 days pregnant and prescribed an alternative/off-label regimen of mifepristone and misoprostol which has not been evaluated or approved by the Food and Drug Administration (FDA).

Isis received the mifepristone abortion pill (RU-486, Mifeprex) to take orally at the clinic. Mifepristone inhibits and blocks the essential reproductive hormone progesterone that plays a critical role for the initiation and maintenance of pregnancy.

Before leaving the clinic, she was briefly instructed to vaginally insert misoprostol that same evening, just before bedtime, to induce contractions to expel the embryo and placental tissues.

For Isis, her experience with the clinic's staff and the lack of information she had been given about the abortion pill procedure was a disappointing failure. She now hopes to warn other young women about her abortion pill experience which she describes as a “freakish nightmare.”

Isis’ story is followed with an interview that reveals the insights of a confused naïve young woman at the hands of an abortion clinic and industry that victimized her and took advantage of her vulnerable condition.

She feels, abortion clinics, “are motivated by profit rather than health" as women are hurried through a process, given scant materials, prescribed off-label abortion drugs, and shoved out the door.

When medical abortion counseling and the process runs afoul, information given to the patient may be misleading and there may be a lack of informed consent. Patients need to learn there are many important medical abortion risks and issues to consider. It is clear, Isis had been given little information on the procedure she was about to undergo.

Additionally, as required by BWMC's Prescriber's Agreement with the drug manufacturer and Federal law, Isis had not been given the required copies of the Mifeprex Medication Guide and Patient Agreement to take home with her before leaving the clinic for her reference and in the event she experienced a serious complication or health risk that required her to go to a hospital emergency room (ER).

In the interview, Isis unselfishly offers her feelings about her abortion choice, thoughts about family support, the disillusionment and misinformation with her medical abortion procedure, and what young women should know before choosing the  abortion pill to end early pregnancy.  This is Isis' Story.

ISIS' STORY: ABORTION PILL EXPERIENCE

The Clinic – The Research – The Choice

To start off, I went to a terrible clinic located on Willougby Street in Brooklyn, New York. These people where rude, unprofessional and very cold.

"I chose the pill method because I felt it would be the easier and safer solution … Wrong!!"

I did my basic Google research like any naive young woman with their first unplanned pregnancy and I spoke to the doctors, nurses or PAs at various clinics and I always got a different answer when it came to how early I was able to take the pill.

I was 5 weeks and 4 days when I was administered RU-486 , I was given the usual one pill (mifepristone, RU-486) that would soften the uterus and told to insert the other 4 pills (misoprostol) into my vagina that same night. I followed instructions and stayed in bed and waited.

What Happened After Taking The Pills – The Scare of Isis' Life

Within 3 hours I was lightly bleeding and had chills. By the 5th hour I got up out of bed feeling like I was on 10 different drugs, I was dizzy and I felt like I needed to poop and pee badly. When I got up and sat on the toilet a gush of what I believe is placenta came out and I had diarrhea.

"I was in pain… not just cramps, but utter exhausting pain. My whole body felt wobbly and drained. I've never felt this before and I believed in that moment I would die!"

My body couldn't handle it anymore and I doubled over and hit my head on the corner of the sink. I was slowly slipping out of consciousness so I felt nothing when I hit my head. Next, I knew I woke up on the bathroom floor, still drowsy and barely able to walk.

"I looked into the toilet bowl and I saw a huge blood clot … NOT the size of a lemon, but the size of a soft ball!"

I flushed the toilet and the worse came.

"I stumbled to the bed room and my vision became darker and very soon I was blind. Yes, I was blind and more scared than I've ever been in my whole life!"

I stumbled  to the bedroom calling out for my boyfriend I felt my way to the room by keeping my hands on the walls.

"All I could do was yell "I can't see I can't see! Help!"

After knocking over a few things,  I fell back against the wall. I soon had trouble breathing and couldn’t catch my breath, I believe I was having a panic attack but I'm still unsure what it really was. My body became hot and I kept opening my eyes and closing them. I was still blind.

I tried to calm myself and my boyfriend tried to convince me that I was being dramatic.He couldn’t believe I had lost my sight.

"I shut my eyes and tried to recuperate for five minutes praying to God. I opened my eyes and finally I could slightly see my hand in front of my face."

I asked my boyfriend to bring me juice because I figured it was the loss of blood and fluids that was the reason I was blind. I drank the juice and my vision restored fully, my boyfriend opened the window and let some cold air in and soon enough I felt better. I went back to sleep.

What Isis Learned About the Abortion Pill

I am writing this story two days after this whole ordeal. My stomach still feels a bit weird and I have light bleeding. Hopefully, the worst is behind me.

"I would not recommended this pill to my worst enemy and I urge other young women to make more informed choices."

If I had known then what I know now, I would have done the surgical method.

INTERVIEW: ISIS' ABORTION PILL EXPERIENCE

Interview: April 15-19, 2013

MONTY PATTERSON: Isis, I want to thank you for sharing your story especially when you are in such a difficult and challenging time in your life. You are a brave young woman. You have an important and powerful story that many young women will be able to relate to. Can you briefly tell something about yourself?

ISIS: "I’m a pre-veterinary student at Fordham University and I am 22 years old. I currently manage a dog daycare and boarding facility."

MONTY PATTERSON: Looking back on your recent medical abortion pill experience, what advice would you give other women who are trying to make a decision about what to do and what would you have done different?

ISIS: "I would tell other women to not panic and make rush decisions, because when “We” do that we become prey for these so called medical professionals who just want to get paid and do a minimal amount of work."

"I wish I had spoken to my parents first because if they knew I’m sure I would be able to make a wiser choice because the truth is, these PAs (physician assistants), and RNs (registered nurses) don’t care for us like our parents will. Women in these situations almost NEVER get to see a doctor unless they pretty much fight the nurses for an appointment."

"Instead, we get PAs and RNs who strut around in white coats pretending to be doctors. As a matter of fact while I was at that clinic, I had a nurse tell me I could take the pill as soon as possible and I had a PA then tell me only until 4 weeks. Yet, they had posters on the wall that said the pill could be taken the minute you find out your pregnant."

"I was so confused and I felt helpless, I was treated like a confused helpless little girl and yelled at when I inquired about more information."

MONTY PATTERSON: How do you feel that your parents or other members of your family could have helped with your pregnancy decision because it seems that most young women want to keep it a secret? What about your boyfriend, would he have wanted your parents to know about your pregnancy?

ISIS: "I feel if my parents or anyone older and more-wiser had known, I wouldn't have been pushed around and made rash decisions. I would've been safer, but it can turn out badly too. My boyfriend wanted me to tell them, but I didn't want to go through the embarrassment or the “I told you so's.”

"I wanted my freedom and I didn't want this to have an impact on whatever decisions I made in the future."

Because believe it or not when things like this happen our mode of thinking is if we cry to our parents for help, we show that we are not capable of being independent or that we’re giving our freedom away by running back to mom and dad."

"In some cases I hear the comments my parents make about young girls who are pregnant or get abortions and they're never nice things. I didn't want to be that image in their mind."

MONTY PATTERSON: You mentioned that you had visited a terrible clinic located at Willoughby Street in Brooklyn, New York. Was it the Best Women's Medical Care (BWMC) clinic?

ISIS: "Yes, that’s the name of the clinic that I received "care" from."

MONTY PATTERSON: As you understood it, the clinician said you had to be at least 4 weeks pregnant before you could be prescribed medical abortion drugs. Did the clinic perform a sonogram (ultrasound) to view the image and determine the length of your pregnancy?

ISIS: "Yes. They did the sonogram on Saturday (April 6^th) and then on Thursday (April 11^th). They were able to see the baby on Thursday but not Saturday." "And what's strange is when they did the sonogram that Saturday (April 6^th) they told me they saw nothing and I was too early, but by Monday (April 8^th) I received a call saying that my pregnancy would be viewable by Wednesday (April 10^th). I went in on Thursday (April 11^th) and they told me I was now 5 weeks and 4 days."

MONTY PATTERSON: Were you able to see the clinic’s medical doctor at any time before, during or after you were prescribed the abortion pill regimen of mifepristone (RU486, Mifeprex) and misoprostol?

ISIS: "I didn't ask to see the doctor because I assumed that something like this would be handled by a doctor. It was only until after I realized that everything I been through so far has been handled by staff beside the doctor."

"I knew I wanted to be handled by a doctor. When I asked the nurse about information about the pill and when I pointed out the conflict between their advices she said, it's whatever the PAs say."

MONTY PATTERSON: At the end your story, you mentioned that instead of a medical abortion you would have done a surgical abortion (vacuum aspiration abortion). Did they offer it to you surgical abortion or did the clinic push the abortion pills?

ISIS: "They did not discuss any options with me and pretty much just let me have the pill because it was the first thing I mentioned."

"I took a blood test and in two days they called me back and told me I could come in for the pill."

MONTY PATTERSON: When did the clinic give you the first pill (mifepristone) to terminate your pregnancy and when were you told to take the second set of pills (misoprostol) to induce labor contractions?

ISIS: "I was given the first pill on April 11 at about 3:30 p.m. and I was told to insert the second set (4 pills) vaginally before I go to sleep that same night. They were very cut and dry with me. They even gave me a sheet of paper with very brief instruction."

"Not once was the word antibiotic even mentioned!"

"I felt victimized by these people. They did not tell me what to expect AT ALL."

"She simply told me to insert the pills and make sure I’m lying down for 5 hours, and that I should take Motrin beforehand."

MONTY PATTERSON: Did the clinic offer to provide you a prescription for any type of pain medication other than tell you to take over the counter Motrin?

ISIS: "None whatsoever! In her exact words, Oh and Motrin for the pain."

"Also, I was only told there would be large blood clots but not to worry and if I have a fever over 100° to call the ER and to come back in two weeks."

"I thought it was simple and easy."

MONTY PATTERSON: Who told you not to worry about the side effects of medical abortion?

ISIS: "It was the RN. She made it seem like whatever was going to happen was not a big deal. Even the sheet they gave me made it seem that way."

MONTY PATTERSON: During your consultation, did the clinician review the Mifeprex Medication Guide with you, answer your questions and explain that cramping and bleeding are an expected part of ending a pregnancy but serious and potentially life-threatening bleeding,  infections, or other health risks can occur following a medical abortion?

ISIS: "What consultation? ABSOLUTELY NOTHING was explained to me. I had to find these things out on my own. The one time I sat in the office I was too scared of getting yelled at to ask questions. The RN just sat in her chair and told me I'm too early for the pill and when I asked about my options she snapped at me "what do you mean what options? There's nothing to abort!"

"I was treated like cattle or I didn't know what I was talking about, and the fact is, I didn't know much about this stuff, that's why I was there, to get help and information which I obviously didn't get."

MONTY PATTERSON: When you were told, if you have a fever over 100 degrees that it may be a symptom of a serious or fatal infection complication and you should contact your provider (meaning the clinic) right away?

ISIS: "That's another story. The word infection was NEVER mentioned. Her exact words, if you have a fever of over 100°… go to the ER."

"I felt like she couldn't wait to get me out the office and when I asked her to explain again the procedure that I had to do that night she sighed of frustration and began in a harsher tone."

"This was during the second visit where she tried to be nicer to me because after she had yelled at me during the first visit, I sternly explained to her that I didn't have time to be pushed around because I work and I'm in college and needed to know what was going on."

"She responded with "what college do you attend?" After I told her, it was Fordham, she sweetened up to me as if now I'm worthy of a decent response. It makes you wonder."

MONTY PATTERSON: Did the clinic give you a hotline number to call in the event you needed their help or advice?

ISIS: "No"

MONTY PATTERSON: When the clinic told you to “go to the ER”, did they tell you to take your paperwork and the Medication Guide with you if you visit the emergency room (ER) or a provider who did not give you Mifeprex (mifepristone, RU-486) so that they would understand that you are having a medical abortion?

ISIS: "What Medication Guide? I was never given a Medication Guide. Thanks for providing me that link (FDA website reference). Now, sadly, I’m just learning this vital information. Thank you."

MONTY PATTERSON: Were you given a Patient Agreement Form to sign that is required by the clinic.

ISIS: "I was given a form to sign I believe it is that form but I’m not sure. I’m going try to get a copy today of that contract because I'm now seriously considering pressing charges."

MONTY PATTERSON: Did the clinician tell you that they were offering you an “Alternative/off-label” abortion pill regimen that was not approved by the FDA? Did they explain this and have you sign forms explaining you were being prescribed a “alternative” medical abortion regimen that was completely different than the FDA version?

ISIS: "No. Not-at-all."

MONTY PATTERSON: You were given mifepristone to take at the clinic and later told to insert misoprostol in your vagina at home. Did you get detailed instructions for the home use of misoprostol and what to expect after you inserted the tablets?

ISIS: "The instruction I got from them… makes everything seem so easy, huh? Doesn’t tell much about anything."

BWMC Steps Taking RU486 (Abortion Pill) These are the basic "At Home Procedures" Isis was given to follow. Note: Step #3 actually refers to the second drug "misoprostol" that induces labor contractions.

MONTY PATTERSON: As a young woman, under duress due to an unintended pregnancy, were you truly able to understand, take the time to review and sign all the paperwork required to get a medical abortion?

ISIS: "No. I felt rushed when the contract was given to me and so I signed it."

MONTY PATTERSON: Did the clinic do their job by fully explaining medical abortion along with what you needed to sign to proceed?

ISIS: "Reading it now, they definitely didn't fulfill their end of the bargain. And when I say absolutely nothing was explained, I mean NOTHING not even a PAMPHLET!"

MONTY PATTERSON: It appears the clinic did not give you the required informed consent forms to take home with you explaining the abortion pill procedure, important information you should know, side effects, and possible risks.

ISIS: "I received nothing of the sort. I’m COMPLETELY IGNORANT to anything having to do with this pill, until I got in contact with you and did some online research. I was given that piece of paper (steps taking the RU-486 abortion pill) and another piece discussing the price and how much they would charge me etc."

MONTY PATTERSON: Did you feel the clinic failed you as a patient?

ISIS: "Definitely!"

MONTY PATTERSON: In your story, you talked about some Google research on the medical abortion pill. What have you learned since then?

ISIS: "When you feel like Google is a better doctor to you than the actual clinic staff, something is wrong."

"Fact is a lot of women are going to use Google to find information about abortion and we will usually get “watered-down-sugar-coated” information directly from clinics."

"I feel women need to know the cold hard truth, because right now as we speak I’m still scared for my life."

MONTY PATTERSON: In your Google search did you feel the websites you visited marketed mifepristone (RU-486) medical abortion over surgical (vacuum aspiration) abortion?

ISIS: "I'm not sure. The way this pill is marketed, is "have the abortion in the privacy of your own home" and I had to learn through a friend that the surgical procedure isn’t as scary as it sounds. Matter of fact she was absolutely fine."

"Through my experience I learned that the privacy of my own home doesn’t necessarily mean that it’s safe."

"By using those terms they make it appear easier and simpler. Of course, scared confused young women will try to opt out of surgery."

MONTY PATTERSON: While searching the internet or when you visited the clinic, did you learn the FDA warns about the risk of fatal infections and death where women were given misoprostol vaginally instead of orally? Did you know under the FDA approved regimen, misoprostol is given orally?

ISIS: "No. My gut feeling told me something wasn't right when I was told to insert (misoprostol) vaginally. I trusted the nurse and did it anyway. My gut feeling went against it because in my Google research I never or hardly came across any stories where women said they had to insert the pills vaginally. Almost all of them took the pills by mouth."

MONTY PATTERSON: At this time, when you are still trying to recover from your medical abortion, why are you still scared for your life?

ISIS: "Because I still get an uncomfortable feeling in my stomach and I am afraid of infection. The bleeding had been getting heavier on and off and also I find it hard to trust these clinics. I even feel they could’ve given me the wrong dose because they're so incompetent."

MONTY PATTERSON: Do you feel women are being taken advantage of by abortion clinics? Do you think clinics are motivated more by profits rather than the patient’s safety and health?

ISIS: "I’m not going to say all women are being taken advantage of, but by what I've seen the majority of them are, simply because when we find ourselves in a situation like this (unexpected pregnancy) we usually keep to ourselves because we're embarrassed or ashamed of the situation we’re in or we’re terrified to tell someone wiser like parents or relatives who are actually capable of making a non-panicked decision."

"So naturally we try to fix the problem ourselves and what ends up happening is women throw their trust to these abortion clinics hoping they're in safe hands. The clinics know this and know that at this time they're the ones in control, not mom and dad, so whatever they say we will follow because they're wearing a white coat and seem like they have our best interest in mind."

"I definitely think clinics are motivated by profit rather than health, there are a few good ones out there, but the reason I had to stay at such a terrible one was because it actually cost more money to switch!"

"I called a better clinic and the only way I could start using them was if they could do all the test that the other clinic did (sonogram and blood test)  which I of course had to pay for. I asked them if they could just use the result from my previous clinic and they said policy didn't allow it."

MONTY PATTERSON: Do you think there could be more injuries, maybe deaths, to young women from medical abortion pills than is known because they may be too afraid to seek help or come forward and tell their story?

ISIS: "I think there are a lot more women who were hurt by RU-486 but they probably just want to forget that time in their life existed. And for the most part, we’re embarrassed to talk to our girlfriends about abortion much less the world, so we're not going to find people coming out with their stories."

"We need more girls to speak up!"

"I think this pill shouldn't be treated as lightly as they are treating it. When a woman has a miscarriage she is rushed to the ER to see a doctor, why are we not letting doctors handle patients who have to take this pill that CAUSES MISCARRIAGE? Why aren't there strict instruction and procedure?"

MONTY PATTERSON: How did you find out Holly's Story and the website http://abortionpillrisks.org/ ?

ISIS: "I Googled to try to see if anyone had a similar experience. And I found Holly’s story then the website."

"They (the clinic) never told me of ANY risk involved and then I read about Holly's story and was furious! It was a MAJOR wake up call for me."

"They make it seem so simple because they are marketing to young scared women who probably won’t fight back because they don’t have their parents at their side. They know it and they take advantage of us because of it."

MONTY PATTERSON: Thank you for sharing your feelings and thoughts about your frightening experience with RU-486 medical abortion. You are very courageous to stand up and tell your story.

ISIS: "Thank you for contacting me so this story can be published and possibly save lives."

Page Last Updated: April 28, 2013

A Woman’s Abortion Pill Experience

 Women sometimes share their personal experiences as a way to empower other patients through  knowledge. This community can sometimes be found at a website or a group forum where a voice is given to a group of women known to suffer in silence as they relate to truly understand each other’s challenges.⁽¹⁾

Some of the following statements are from one woman’s experience, as she describes her ordeal to others in a group forum, about her early pregnancy termination with the abortion pill.

“Almost a year ago I had a medical abortion. And not to scare you, but it was one of the worst experiences of my life.”⁽¹⁾

The Pain and Bleeding

Recognizing that medical abortion experiences and bleeding complications can vary from one woman to another, she stated:

“Because of my experience with the medical abortion, I don’t think I could ever do it again (not that I plan on having an unplanned pregnancy again).”⁽¹⁾

Even though she had been prescribed painkillers, the severe pain from cramping and heavy bleeding was unbearable. Bleeding was one of her biggest concerns. She feared going to the bathroom because of the resulting blood clots and blood loss associated with medical abortion. ⁽¹⁾

• Most patients will initially experience moderate to heavy bleeding, with clots ranging in size from small (size of a dime) to very large (size of an orange) during medical abortion. ⁽²⁾

Her first 3 or 4 days of bleeding were the worst. ⁽¹⁾After bleeding for over 6 weeks, she experienced further bleeding complications due to hemorrhaging which is best defined as the loss of large amounts of blood. ^{(1) (3)}

Recognizing Bleeding Complications

• Early identification of excessive bleeding may help to prevent the risk of serious health complications. Early recognition is particularly important when the patient is at home. ⁽⁴⁾
• Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications. ⁽⁵⁾
• It is important for patients to be aware of the risk of severe bleeding that may be caused by trauma (to the vagina, cervix, uterus) or retained pregnancy tissue, infection, uterine atony or rupture. ^{(4) (6) (7)}

Hemorrhaging and Medical Abortion Failure

After being admitted to the emergency room, it appears she was evaluated with bleeding complications and medical abortion failure resulting from retained pregnancy tissue that was stuck in her uterus. A surgical abortion procedure, known as vacuum aspiration, was performed on her to remove the pregnancy tissue. ⁽¹⁾

• Vacuum aspiration is frequently used as the first option treatment for hemorrhage; this enables the uterus to contract and decrease bleeding. ⁽⁸⁾
• Severe hemorrhage and prolonged heavy bleeding require immediate attention. With significant bleeding; fluid replacement, blood transfusion and oxygen administration should be considered. ^{(5) (8)}
• Some women may experience a heavy bleeding episode 3-5 weeks after the abortion. A curettage procedure by surgical scraping and scooping to the lining of the uterus may be required to stop heavy bleeding in about 10 per 1000 women. ⁽⁹⁾
• Medical abortion failure also known as incomplete abortion may increase the risk of infection and is associated with discomfort as persistent or recurrent bleeding and pain.⁽⁵⁾

Her Evaluation of the Abortion Pill Experience

At the end of her medical abortion pill experience, she stated:

“Had I known all that was going to happen, I would have opted for the surgical abortion. Also, I had a lot of guilt during the whole process and no one to talk to about it… which I’m sure didn’t help the situation.”⁽¹⁾

Understanding the Health Risks of Medical Abortion

Medical abortion may be new and unfamiliar to many women. A woman making an abortion decision needs to understand the risks, benefits, and options available that is in the best interest of her health, safety and welfare.

It is important for women to understand the warnings for serious and sometimes fatal infections and bleeding which occur following the use of Mifeprex (mifepristone) for medical abortions.

Since mifepristone’s approval in September 2000, the U.S. Food and Drug Administration (FDA) has received reports of serious adverse events, including women who have died, in the United States and other countries following medical abortion with mifepristone and misoprostol.

The most publicized medical abortion death was Holly Patterson from Livermore, California who died September 17, 2003.

To learn about the risks of the medical abortion, please visit the site http://abortionpillrisks.org/ for more information.

REFERENCES

1. Experience Project, pnkdi member. I Had An Abortion, Forum & Chat Board, abortion pill: what to expect. Experience Project. [Online] October 16, 2011. [Cited: September 12, 2012.] http://www.experienceproject.com/groups/Had-An-Abortion/forum/Abortion-Pill:-What-To-Expect/66199.

2. National Abortion Federation. Management of Side Effects and Complications in Medical Abortion: A Guide for Triage and On-Call Staff. Early Options, National Abortion Federation. [Online] September 2008. [Cited: August 31, 2011.] http://www.prochoice.org/pubs_research/publications/downloads/professional_education/medical_abortion/phone_triage_guide.pdf.

3. Kruse, Beth, et al., et al. Management of side effects and complications in medical abortion, Am J Obstet Gynecol. Vol 183, Number2. NCBI, PubMed. [Online] August 2000. [Cited: September 6, 2011.] http://www.ncbi.nlm.nih.gov/pubmed/10944371.

4. Lichtenberg, Steve, Grimes, David and Paul, Maureen. A Clinician’s Guide to Medical and Surgical Abortion. s.l. : A Churchill Livingstone title, 1999. ISBN # 0-443-07529-8.

5. U.S. Department of Health & Human Services. Drugs@FDA, Mifeprex (mifepristone) Label and Approval History. FDA, U.S. Food and Drug Administration. [Online] April 27, 2009. [Cited: July 12, 2011.] http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory.

6. IPPF – Marcel Vekemans. First trimester abortion guidelines and protocols. International Planned Parenthood Federation . [Online] September 2008. [Cited: June 23, 2011.] http://www.ippf.org/NR/rdonlyres/D84AFDB1-B6CC-4899-8E3C-5D3392A85F8F/0/abortion_protocol.pdf.

7. IPAS India. Refresher course for medical abortion services, Reference manual, REFMA-IND-E09. IPAS. [Online] March 15, 2009. [Cited: January 17, 2011.] http://www.ipas.org/en/Resources/Ipas%20Publications/Refresher-course-for-medical-abortion-services-Reference-manual.aspx.

8. IPAS. Medical Abortion Training Resources, Medical Abortion Study Guide, Using medicines for first-trimester pregnancy termination. IPAS. [Online] 2009. [Cited: September 8, 2011.] http://www.ipas.org/Publications/Medical_abortion_training_resources_%5BMulti-language_CD%5D.aspx. ISBN: 1-933095-46-6.

9. Medabon. Medabon Medical and Service Delivery Guidelines. Medabon. [Online] 2009. [Cited: September 9, 2011.] http://www.medabon.info/medical.php.

AUSTRALIA has reported its first medical abortion death of a woman who terminated her early pregnancy at home using the abortion pill otherwise known RU-486 or mifepristone.

Little is known about the details and circumstances surrounding her death including; her age, where she died, how many weeks she was pregnant, what type of medical abortion regimen was prescribed to her, or if the medical examiner tested her for a wide range of bacterial infections which includes the lethal Clostridium sordelli pathogen that has resulted in the majority of sepsis deaths in the U.S.

The country’s newspaper, The Australian, reported on March 19, 2012 that a woman died of sepsis “some days after” after she was prescribed an abortion pill regimen at one of Marie Stopes International Australia’s clinics back in 2010. ^{(1) (2)}

At that time, the Australian Therapeutic Goods Administration (TGA), Marie Stopes International Australia (MSIA), TGA Medical Officer Dr. Anthony Gill, and well known abortion advocate Professor Caroline De Costa commented on medical abortion issues including; patient care, procedures, and the first known death in Australia from the mifepristone abortion pill.

However, on March 31, journalist Angela Shanahan, for The Australian angrily responded with her opinion about the danger signals in response to the abortion drug death: ⁽⁴⁷⁾

Angela Shanahan: “Why did it take two years for her death to become public? RU486 was legalized after great public outcry… Did the authorities not think the medical profession and public might like to know about this?” ⁽⁴⁷⁾

Angela Shanahan: "RU-486 (mifepristone) was supposed to be of huge benefit to women. The abortion pill was meant to prevent the problems associated with surgical abortions, the emotional and physical trauma and the ghastly possible complications, and suitable for women in remote areas which, as this poor woman's death shows, it definitely is not." ⁽⁴⁷⁾

Obviously, the debate about the risks of medical abortion in Australia is far from over.

This article will also briefly discuss Clostridium sordellii toxic as as an emerging infection following medical abortion, the experimental status of mifepristone in Australia, Marie Stopes International regimens, unapproved regimens used by in the U.S., and the international record of known medical abortion deaths as a result of the prescribed use of mifepristone and misoprostol to terminate early pregnancy.

Medical Abortion Death Confirmed by the TGA

The Australian Therapeutic Goods Administration (TGA) publicly confirmed the death of a woman who was administered the abortion drug in 2010. ⁽²⁾

The TGA – Australia’s government agency responsible for approving drugs – issued a notice to medical abortion prescribers advising them to take a more active role in following-up with patients who are issued the drug. ⁽¹⁾

It was reported the woman died from group A streptococcus sepsis, a severe bacterial infection of the bloodstream – some days after being prescribed a regimen of two drugs, RU-486 (mifepristone) and misoprostol, from a Marie Stopes International Australia (MSIA) clinic. ^{(1) (2)}

Woman Dies under Marie Stopes International Australia (MSIA) Clinical Care

A review of the MSIA website reveals there is no mention, in its media releases or coverage, of the Australian woman’s death while under their care.

Australian media sources reported that MSIA mentioned the coroner's office, in a state it does not name, reviewed the medical reports and other evidence in this case but did not proceed with an inquest and closed the matter. ^{(1) (2)}

Both MSIA and the TGA refused to release details of the abortion pill fatality, citing respect for patient confidentiality. ⁽¹⁾

MSIA mentions on their website that medical abortion may be performed from 5 weeks gestation to up to 9 weeks gestation and is an alternative to surgical termination and both have unique advantages and disadvantages. These include the time taken to complete the procedure, the number of clinic visits required, effectiveness, side effects and complications. ⁽³⁾

• The website doesn’t appear to reveal any information about the risks of medical abortion complications where infection and hemorrhage are the most frequent serious and life-threatening causes of mifepristone related medical abortion illness and death. ⁽⁴⁾
• MSIA’s medical abortion FAQ’s doesn’t further disclose that incomplete medical abortion may increase the risk of infection and is associated with discomfort as persistent or recurrent bleeding and pain. ⁽⁵⁾

The U.S. Food and Drug Administration (FDA) has already concluded that serious or fatal infection involving the bloodstream after medical abortion may be possibly related to the use of mifepristone and misoprostol. ⁽⁶⁾

Australian Medical Abortion Death Case Was Surprising Closed

Jill Michelson, clinical services director of Marie Stopes International Australia (MSIA) said of the woman's death: "This is a tragic outcome and our sympathies are with her family.”

“The coroner dispensed with holding an inquest, and the case is closed." ⁽¹⁾

 Caroline De Costa, a professor of obstetrics and gynaecology at James Cook University in Cairns, says she also accepted that decision. ⁽²⁾ However, she appeared to have some concern about this decision.

“I find it a little surprising but that's, it's… I know nothing more about the case.” ⁽²⁾

  Angela Shanahan, journalist for The Australian,  is not satisfied with these evasive responses as to why the woman's death will not be investigated further.

“The coroner has decided that her death will not be investigated, despite the fact the RU486 was provided in a clinic that is part of the biggest abortion business in Australia, Marie Stopes International Australia.” ⁽⁴⁷⁾

Why was this case not important enough to investigate?

An inquest is an official or judicial inquiry that is particularly held to determine the cause and details of a person’s death. ⁽⁷⁾

The limited information that has been provided does conclude the woman’s death, confirmed only now, is linked to the use of mifepristone (RU486) since its introduction to Australia in 2006. ⁽¹⁾

Australia’s TGA Medical Officer for Experimental Mifepristone (RU-486)

In Australia, Dr. Anthony Gill, TGA Medical Officer of the Experimental Products Section, is responsible for mifepristone medical abortion and its communications.

Monty Patterson of Abortionpillrisks.org website asked Dr. Tony Gill about medical abortion in Australia and details of the 2010 sepsis death of a woman who was reported to have died from Group A Streptococcus (GAS).

Dr. Gill responded briefly with the following points: ^{(8) (9)}

• Mifepristone (RU-486) is currently not approved for marketing in Australia.
• Only authorized medical practitioners can prescribe mifepristone as an unapproved therapeutic drug.
• Since mifepristone is not approved for marketing, the TGA does not regulate medical abortion procedures or regimens used in Australia.
• Medical abortion prescribers are responsible for determining the needs of the patient and to monitor the outcome of their own therapy.
• The TGA notice that was previously issued to mifepristone prescribers, after the sepsis death of a woman following medical abortion, was not available for the public’s review.

When asked, Dr. Gill did not provide a response on the following questions:

• Was the patient administered vaginal misoprostol? (All sepsis deaths in the U.S. have resulted with unapproved vaginal use of misoprostol with the exception of one case) ⁽¹⁰⁾
• Did the coroner’s investigation of the patient’s death include specific DNA testing to identify a broad range of bacterial infections that also included the Clostridium sordellii pathogen?
  • Clostridium sordellii associated Toxic Shock (CATS) infections following medical abortion have become the leading cause of sepsis death in U.S. women.
  • Group A Streptococcus (GAS) infections can cause an illness resembling toxic shock syndrome (Streptococcal Toxic Shock Syndrome or STSS). Persons at higher risk for this invasive disease may include those with compromised immune systems. ⁽¹¹⁾
  • CATS ^{(12) (13) (14)}and GAS infections could take advantage of a patient’s immune-compromised condition due to potential anti-glucocorticoid effects of mifepristone that may alter or impair the body’s immune response following medical abortion.

Clostridium sordellii the Emerging Medical Abortion Infection

The U.S. Food and Drug Administration (FDA) and U.S. Center for Disease Control (CDC) have acknowledged Clostridium sordellii as an emerging bacterial infection associated with toxic shock following medical abortion with a 100% fatality rate. ^{(15) (16)}

Clostridium sordellii is present in the vagina in 5% of all women and in up to 29% of women after pregnancy loss. ⁽¹⁷⁾

Symptoms seen with clostridial infections include weakness, nausea, vomiting or diarrhea with or without abdominal pain that persists after expulsion of the pregnancy. Although patients typically lack a fever, they exhibit rapid pulse, low blood pressure, and very high red and white blood cell counts. ^{(18) (19)}

Healthcare practitioners in the U.S. have been advised by the FDA to be vigilant so that patients suspected of having an infection, undergoing a medical abortion, are immediately given antibiotics that would treat infections with bacteria such as Clostridium sordellii. ⁽¹⁰⁾

Experimental Medical Abortion in Australia

The Australian Therapeutic Goods Administration (TGA) has allowed the limited introduction of the drug mifepristone to Australia for the purpose of early medical abortion. ⁽²⁰⁾

TGA authorized prescriber forms on its website state; the agency is unable to vouch for the quality, safety or efficacy of an unapproved product (for example: mifepristone), and that its use is regarded as experimental. ⁽⁹⁾

The unapproved prescribed use of the two drug medical abortion regimen of mifepristone and misoprostol for Australian women has been granted special access under an experimental scheme. ⁽²¹⁾

Unapproved therapeutic goods have undergone little or no evaluation of quality, safety or efficacy by the Therapeutic Goods Administration. ⁽⁹⁾ The responsibility for prescribing an unapproved product rests with the prescriber. ⁽⁹⁾

This responsibility would apply to all medical abortion prescribers including Marie Stopes International Australia (MSIA).

Australian Abortion Advocate: Professor Caroline De Costa

Caroline De Costa, a professor of obstetrics and gynaecology at James Cook University in Cairns, has been a prominent advocate for the introduction of medical abortion to Australia. ⁽²⁾

She made headlines when she became the Australian Medical Association’s (AMA) spokesperson on the abortion pill, RU-486. ⁽²²⁾

In 2006, Marie Stopes International Australia (MSIA) congratulated Professor De Costa on her achievement for helping to gain approval to import the first shipment of RU-486 from a New Zealand company. ⁽²³⁾

The revelation that Australia has recorded it first death related to use of the abortion pill RU-486 (mifepristone) has prompted a warning from the Professor De Costa who supported the drug's legalization in Australia. ⁽²⁾

Professor De Costa Comments About Medical Abortion Deaths

The Recent Medical Abortion Death in Australia

After the woman’s death in Australia, Professor De Costa said her death was caused by an infection that occurred after the abortion. ⁽²⁾

She stated, “The organism, the bacteria, I have heard was a group A streptococcus." ⁽²⁾

"This is very susceptible to antibiotic treatment, so it would seem that it's possible if antibiotic treatment had been introduced early for this woman then it might have made some difference, but I really can't say that." ⁽²⁾

Professor De Costa is worried it is very likely there may be some sort of danger of a backlash against mifepristone (RU-486) because of this death. ⁽²⁾

She thinks, “We have to be very clear that if we're going to continue using the drug for early medical abortion and using it at home then services have very, very good mechanisms in place for looking after women once they actually leave the clinic.” ⁽²⁾

De Costa on Medical Abortion Deaths in the United States

In a 2005 medical journal article, Professor De Costa, wrote “It is true that there have been some deaths associated with medical abortions.” ⁽²⁴⁾

Women have died in the U.S. from sepsis following a mifepristone induced abortion where Clostridium sordellii, a pathogen that produces a powerful lethal toxin, was the causative organism. ⁽²⁴⁾

The article pointed out that Clostridium sordellii had also been previously reported in American literature as a cause of death after normal or operative vaginal delivery and gynaecological surgery. ⁽²⁴⁾

Professor De Costa states: “It could be postulated that the women who developed C. sordellii infection after medical termination might equally well have developed the infection had their pregnancies proceeded to term.” ⁽²⁴⁾

Does Caroline De Costa dismiss the latest Australian 2010 sepsis death of the woman as potentially unavoidable?

De Costa’s statement appears to conclude that a healthy pregnant woman who chooses either a medical abortion procedure or decides to proceed with a full term pregnancy, the choice may be irrelevant because chances are she may be predisposed equally to the risk of fatal infection.

The facts are clear, healthy women have died and have been seriously injured after taking medical abortion drugs to terminate their early pregnancies. ⁽²⁵⁾

For a healthy woman, medical abortion drugs that lead to a cascade of serious or lethal  adverse events are the real problem, not the pregnancy itself.

The risks of severe, life-threatening, or even lethal adverse events, such as infection and sepsis, have been documented in otherwise healthy young women who have used mifepristone and misoprostol for medical abortion. ^{(4) (16)}

De Costa did state that she really couldn’t say if antibiotic treatments had been introduced early for the woman then it might have made some difference.

The FDA has concluded that serious or fatal infection involving the bloodstream after medical abortion may be possibly related to the use of mifepristone and misoprostol. ⁽⁶⁾

Facts About Infection and Sepsis After Medical Abortion

Sepsis is a potentially life-threatening complication of an infection. ⁽²⁶⁾

• Sepsis is the most common and dangerous in people who have weakened immune systems. ⁽²⁶⁾
• Incomplete medical abortion may increase the risk of infection. ⁽⁵⁾
• Retention of blood clots and decidual fragments in case of incomplete abortion may increase the likelihood of septic events. ^{(27) (28)}

James A. McGregor M.D., an obstetrician and gynecologist, who has practiced fetal and maternal medicine in Los Angeles, California suggests:

"Mifepristone use may impair hosts responses and may predispose to lethal infection caused by toxigenic C. sordellii, other pathogens, and to reexamine the need for mifepristone use in medical termination of pregnancy." ⁽²⁹⁾

De Costa’s Urgency: The Patient’s Medical Abortion Care

Professor Caroline de Costa is now urging doctors to review the way they care for women who've had a medical abortion. ⁽²⁾

Some doctors who are authorized to prescribe RU486 (mifepristone) have been told (by the TGA) to review their protocols for caring for patients who have had a medical abortion and that there must be a renewed focus on patient care after the abortion. ⁽²⁾

"If you are going to have the woman undergoing the abortion processes at home, then you must have very close contact with her.” ⁽²⁾ "And she must know and you must know what arrangements are in place if she should need emergency care or extra care.” ⁽²⁾

“Infection of retained products of conception (fetal and/or placental tissue) is a possibility, and antibiotics may be needed.” ⁽²⁴⁾

"There are guidelines from the Royal College of Obstetricians and Gynaecologists (RCOG) in London which recommend using antibiotics prophylactically for all women, or at least considering this when you're practicing early medical abortion. ⁽²⁾

Angela Shanahan's response to De Costa's statements:

"However, the problem with RU486 is that precisely because it has been encouraged as a method of home abortion, the need for medical follow-up is not a big consideration, especially in the minds of young girls. In the U.S. there have been 14 deaths caused by RU486, and eight of those were because of sepsis. If it is widely marketed by a drug company and, as De Costa and others envisage, replaces most surgical abortions, there may be less involvement of commercial clinics such as MSIA, but a higher rate of complications. The onus for handling these complications will fall on local emergency services." ⁽⁴⁷⁾

De Costa Questions Medical Abortion Procedures Used by Providers

Professor De Costa questions the possibility that the protocols for the prescribed use of RU486 in Australia may need to be reviewed. ⁽²⁾

The procedures used in Australia may vary between prescribers.

De Costa admits once the drug is approved by the TGA to be marketed, she would expect definite medical abortion guidelines to be published either by the TGA or in conjunction with the national licensing of the drug. ⁽²⁾

Marie Stopes International wouldn't say if it will review the procedures in its 14 Australian clinics. ⁽²⁾

Marie Stopes International (MSI) says it has administered 18,000 medical abortions in Australia since 2009 using mifepristone (RU486) in combination with a second abortion drug, misoprostol. ^{(2) (1)}

At the clinic, the patient receives the standard 200mg tablet of mifepristone to terminate the early pregnancy and is sent home with instructions to take misoprostol 24 hours later to induce uterine contractions to facilitate expulsion of the pregnancy. ⁽¹⁾

Angela Shanahan said the TGA and Marie Stopes International Australia had refused to reveal the protocols for medical abortion to a GP obstetrician who covers emergency services for women who may need treatment for post mifepristone abortions. ⁽⁴⁷⁾

Angela Shanahan commented: "In other words, the government's own agency would not reveal the protocols after the use of an abortion drug to an emergency doctor working in a public hospital who might have to pick up the pieces, but instead referred that doctor to the abortion business. A business that is kept afloat by Medicare." ⁽⁴⁷⁾

Marie Stopes International Clinics in the U.K. and South Africa

A brief overview of what medical abortion involves at Marie Stopes’ International clinics in United Kingdom states the abortion pill regimen is available before nine weeks of pregnancy which consists of taking two sets of pills (orally) over two visits (this can be on the same day or separate days) which causes the passing of the pregnancy. ⁽³⁰⁾

In more detail, the Marie Stopes’ clinics in South Africa prescribe a medical abortion pill regimen that can be used for pregnancies up to 9 weeks as follows: ⁽³¹⁾

• 1 Tablet (200mg) of Mifepristone will be administered orally at the clinic.
• 4 Tablets (800mcg) of Misoprostol is taken at home within 24-48 hours of taking the Mifepristone at the clinic; 2 under the tongue and 1 tablet in each cheek.
• The process can take 14 days to complete. Pain and heavy bleeding should subside once the pregnancy has been expelled. Lighter bleeding will continue for 2-3 weeks.
• A follow up visit to the clinic must be undertaken 3 weeks after taking the misoprostol medication.
• If the abortion is not complete misoprostol may be administered as a repeat dosage with another follow up visit 24 hours later.

Unapproved Medical Abortion Regimens Used in the U.S.

In 2000, the US Food and Drug Administration (FDA) approved a mifepristone/misoprostol medical abortion regimen protocol for termination of pregnancies up to 49 days (7weeks) from the first day of the woman’s last menstrual period (LMP). ⁽¹⁶⁾

Once medical abortion providers in the U.S. had FDA approval for mifepristone and misoprostol pregnancy termination, abortion researchers set out to increase the gestational age limit, shorten the process, decrease their costs, change the dosing regimen, allow women to administer misoprostol at home (instead of at the provider's clinic) and reduce the number of patient’s return visits back to the clinic. ⁽³²⁾

The FDA-approved regimen, an oral combination of 600 mg mifepristone followed 2 days later by office-based administration of 400 mcg of misoprostol, has been used in only 4% (4 per 100) of abortion provider facilities since its approval in 2000. ⁽³³⁾

The FDA has issued public health advisories to warn health care professionals about the risks of sepsis in medical abortion and to reinforce use of the approved regimen which does not include the vaginal use of misoprostol. ^{(34) (35)}

International Medical Abortion Deaths – All Causes

Since 2001, at least twenty-one women worldwide have died from fatal complications including hemorrhage, toxic shock, sepsis, organ failure, and ruptured ectopic pregnancy following early medical abortion with mifepristone and misoprostol. ^{(1) (2) (36)}

There have been media reports of a European manufacturer's mention of the potential for additional deaths due to mifepristone and misoprostol medical abortion. It appears there is an official lack of documentation at this time.

International Medical abortion Deaths – Sepsis/Toxic Shock

Bacterial Infections and sepsis (a serious infection involving the bloodstream)

Since 2001, eleven women—one in Canada, eight in the United States, one in Portugal, and one in Australia—have died from sepsis/toxic shock syndrome (nine from Clostridium sordellii, one from Clostridium perfringens, one from Group A Streptococcus) following early medical abortions with mifepristone and misoprostol. ^{(1) (10) (16) (37) (38) (39)}

• 9 women were diagnosed with Clostridium sordellii fatal toxic shock syndrome,
• 1 woman was diagnosed with Clostridium perfringes,
• 1 woman is believed to have died from Group A Streptococcus (GAS)

Medical Abortion Poor Monitoring and Unreliable Reporting

Due to poor monitoring, unreliable and voluntary reporting to international authorities, it is unknown how many women may have died from infections following medical abortion. ⁽⁴⁰⁾

A medical abortion death may only become public knowledge if a report is submitted to a governmental agency or if a person or patient goes to the media to publicize the incident.

Conclusion

Medical abortion with mifepristone and misoprostol has been an expanding alternative to surgical abortion. It has been accelerating in line with experience in the U.S. and Europe, where up to half of all of elective terminations in Australia are now carried out with mifepristone. ⁽¹⁾

The risks of medical abortion can have a serious impact on a woman’s health. Taking an abortion pill may seem to be very easy, but can result in infection and complications that are serious and life-threatening which could lead to hospitalization or death. ⁽¹⁸⁾

Women worldwide deserve to know all the facts and to be well-informed of all potential risks to their health and welfare when considering an early medical abortion termination with mifepristone and misoprostol. ⁽⁴¹⁾

Professor De Costa even stated in her own book, RU-486, that it needs to be made clear that: ⁽⁴²⁾

“Medical abortion using mifepristone and misoprostol is not a Magic Bullet that simply melts the pregnancy away.”

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37. Reis, T, et al., et al. A Clostridium sordellii fatal toxic shock syndrome post-medical-abortion in Portugal, Abstract number: R2542. ESCMID, European Society of Clinincal Microbiolgy and Infectious Diseases, Milan, Italy. [Online] May 7-10, 2011. [Cited: September 12, 2011.] http://www.eccmidabstracts.com/abstract.asp?id=93762.

38. Patterson, Monty L. Health Risks: Medical Abortion Deaths. Abortion Pill Risks, Just the Facts. [Online] 2012. [Cited: March 28, 2012.] http://abortionpillrisks.org/health-risks/deaths/.

39. Sinave, Christian, et al., et al. Toxic Shock Syndrome Due to Clostridium sordellii: A Dramatic Postpartum and Postabortion Disease, Volume 35, Issue 11, pp. 1441-1443. Oxford Journals, Clinical Infectious Diseases. [Online] August 7, 2002. [Cited: September 12, 2011.] http://cid.oxfordjournals.org/content/35/11/1441.full?sid=a2610f54-ca62-403f-bce5-78e2eabb4bcf. doi: 10.1086/344464.

40. Creinin M, etal. Mifepristone-Misoprostol Medical Abortion Mortality. Medscape General Medicine. [Online] April 14, 2006. [Cited: September 2, 2010.] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1785176/.

41. Patterson, Monty L. Abortion Pill Risks, Just The Facts. Abortion Pill Risks. [Online] 2012. [Cited: March 28, 2012.] http://abortionpillrisks.org/.

42. Costa, Caroline De. RU-486, The Abortion Pill. Salisbury : Boolarong Press, 2007. 9781921054334.

43. National Abortion Federation. Module 1, Pharmacolgical Approaches to Early Abortion. Early Options, National Abortion Federation. [Online] 2010. [Cited: June 29, 2011.] http://www.prochoice.org/education/cme/online_cme/m1pharma.asp.

44. Jones, Rachel and Henshaw, Stanley. Mifepristone for Early Medical Abortion: Experiences in France, Great Britain and Sweden. Guttmacher Institute. [Online] May/June, Volume 34, Number 3 2002. [Cited: January 18, 2011.] http://www.guttmacher.org/pubs/journals/3415402.html.

45. Walker, Jamie. National Affairs, Abortion Pill 'less safe than surgery'. The Australian. [Online] May 07, 2011. [Cited: March 20, 2012.] http://www.theaustralian.com.au/national-affairs/abortion-pill-less-safe-than-surgery/story-fn59niix-1226051434394.

46. U.S. Department of Health & Human Services. Label, Mifeprex (mifepristone) Tablets, 200mg, Rev 4:4/22/09. Drugs @FDA, U.S. Food and Drug Administration. [Online] April 27, 2009. [Cited: July 20, 2011.] http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020687s015lbl.pdf.

47. Shanahan, Angela. Danger signals in TGA response to abortion drug death. The Australian, National Affairs, Opinion. [Online] March 31, 2012. [Cited: March 31, 2012.] http://www.theaustralian.com.au/national-affairs/opinion/danger-signals-in-tga-response-to-abortion-drug-death/story-e6frgd0x-1226314778395.

What is the difference between the Morning-after Pill and the Abortion Pill? 

The emergency contraceptive “Morning-after Pill” can prevent an unplanned pregnancy while the "Abortion Pill" can terminate an established early pregnancy.

The Morning-after Pill to Prevent Pregnancy

Emergency contraception pills (ECPs), also known as the “Morning-after Pill”, are used to help prevent a woman from getting pregnant after she has had sex without using birth control or if the birth control method failed. ⁽¹⁾

The term "Morning-after Pill," can be misleading because ECPs don't have to be taken the morning after. ⁽¹⁾

ECPs can reduce the chance of pregnancy when taken as directed up to 72 hours (3 days) after unprotected sex. Some kinds of ECPs can work up to 120 hours (5 days) later. ⁽¹⁾

In the United States, there are several kinds of FDA-approved emergency contraception pills (ECPs). The trade names of the ECPs or morning-after pills are Plan B One-Step, Next Choice and ella. ^{(2) (3) (4)}

Plan B One-Step and Next Choice contain levonorgestrel, a hormone used in birth control pills and are available at drugstores and stores with a licensed pharmacist. The FDA approved Plan B One-Step and Next Choice for sale without a prescription to those 17 and older. Women and men must show proof of age to buy Plan B One-Step or Next Choice. If you are younger than 17 and need emergency contraception, you will need a prescription. ^{(2) (3)}

Emergency contraception pills, such as Plan B One-Step® and Next Choice, when taken as directed, are not effective in ending an existing pregnancy. ^{(2) (3)}

The emergency contraceptive pill, ella (U.S. trade name), is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. ⁽⁵⁾ The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. ⁽⁴⁾

ella is not for use in the case of known or suspected pregnancy. The risks to a fetus when ella is administered to a pregnant woman are unknown. ⁽⁴⁾

The Abortion Pill to Terminate Early Pregnancy

The Abortion Pill, otherwise known as Mifepristone (U.S. trade name: Mifeprex) or RU-486, is a medical or drug induced alternative to surgical or vacuum aspiration abortion for women who elect to terminate an early pregnancy. ^{(6) (7)}

On September 28, 2000, the United States Food and Drug Administration (FDA) approved a combined medical abortion regimen of mifepristone (Mifeprex) with another drug called misoprostol (Cytotec) for termination of pregnancy up to 49 days or less since a woman’s last menstrual period began. ^{(8) (9)}

In the United States, mifepristone is not available to the public through licensed pharmacies. The medical abortion regimen of mifepristone and misoprostol must be provided by or under the supervision of a qualified physician who has met specific qualifications to administer the drugs. ⁽¹⁰⁾

How does the abortion pill regimen work?

Mifepristone blocks a hormone, progesterone, which is needed for a woman’s pregnancy to continue. The mifepristone abortion pill is an anti-progestin that blocks the action of progesterone which is necessary to establish and maintain placental and embryo attachment. ^{(11) (12)}

Mifepristone is used in conjunction with another drug called misoprostol (Cytotec) which stimulates uterine contractions that expel the embryo and placental tissue to complete the medical abortion procedure. ⁽¹¹⁾

Should patients be concerned about the risks of the abortion pill?

Medical abortion with mifepristone and misoprostol has increasingly become an integral part of abortion provision in the United States and likely has contributed to a trend toward very early abortions. ⁽¹³⁾

The continuing increase in the number of medical abortions performed each year and the risk of major health complications is of great interest to patients and health care providers. ⁽¹⁴⁾

Patients may experience adverse events and health risks that can range in severity from complications that are serious and life-threatening to those that can lead to hospitalization or death. ⁽¹⁵⁾

For more information about the Abortion Pill and its risks please visit http://abortionpillrisks.org/.

References

1. U.S. Department of Health & Human Services Office on Women's Health. Publications, Emergency contraception (emergency birth control) fact sheet. Womenshealth.gov, Empowering women to live healthier lives! [Online] November 21, 2011. [Cited: December 2, 2011.] http://www.womenshealth.gov/publications/our-publications/fact-sheet/emergency-contraception.cfm#f.

2. Teva Women's Health, Inc. Plan B One-Step, Levonorgestrel, One Pill. One Step. Plan B One-Step. [Online] 2011. [Cited: December 2, 2011.] http://www.planbonestep.com.

3. Watson Pharma, Inc. Next Choice, Levonorgestrel, Emergency Contraceptive. My Next Choice. [Online] 2011. [Cited: December 2, 2011.] http://mynextchoice.com/index.asp.

4. U.S. Department of Health & Human Services. FDA, Full Prescribing Information, ella Initial U.S. Approval: 2010. FDA, U.S. Food and Drug Administration. [Online] August 2010. [Cited: December 25, 2011.] http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf.

5. U.S. Department of Health & Human Services. FDA, News & Events, FDA approves ella tablets for prescription emergency contraception. FDA, U.S. Food and Drug Administration. [Online] August 13, 2010. [Cited: December 2, 2011.] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222428.htm.

6. Danco Laboratories, LLC. What is Mifeprex. Mifeprex (mifepristone tablets, 200 mg) the early option pill to end pregnancy. [Online] [Cited: June 15, 2011.] http://www.earlyoptionpill.com/section/what_is_mifeprex/.

7. Johnson, Judith. CRS Reports, Abortion Termination of Early Pregnancy with RU-486 (Mifepristone). University of Maryland School of Law, Thurgood Marshall Law Library, CRS Reports:Abortion. [Online] February 23, 2001. [Cited: September 3, 2010.] http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL30866.pdf.

8. Shannon, Caitlin S, et al., et al. Multicenter Trial of a Simplified Mifepristone Medical Abortion Regimen, Volume 105, Issue 2. Obstetrics & Gynecology, The American College of Obstetricians and Gynecologists . [Online] February 2005. [Cited: September 7, 2011.] http://journals.lww.com/greenjournal/fulltext/2005/02000/multicenter_trial_of_a_simplified_mifepristone.22.aspx.

9. U.S. Department of Health & Human Services. Drugs, Mifeprex (mifepristone) Information. FDA, U.S. Food and Drug Administration. [Online] July 19, 2011. [Cited: July 19, 2011.] http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm111323.htm.

10. U.S. Department of Health & Human Services. FDA, U.S. Food and Drug Administration, 9/28/2000 Approval Letter to Population Council. [Online] September 28, 2000. [Cited: July 14, 2011.] http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20687appltr.pdf.

11. UCSF Center for Reproductive Health Research & Policy: San Francisco. Early Medical Abortion: Issues for Practice. Bixby Center for Global Reproductive Health. [Online] July 2001. [Cited: June 15, 2011.] http://bixbycenter.ucsf.edu/publications/files/EMAR.pdf.

12. Ulmann, Andre, Teutsch, Georges and Philibert, Daniel. RU 486. Abortionpillrisks.org. [Online] June 1990. [Cited: July 25, 2011.] http://abortionpillrisks.org/wp-content/uploads/2011/07/RU486_1990.06_Sci-Am_Ulmann_RU486.pdf.

13. Jordan, Beth and Shields, Wayne C. Happy anniversary mifepristone: a decade of promise and challenges. Contraception Journal. September, 2010, Vol. 82, 3, Pages 219-220 .

14. Niinimäki, Maarit, et al., et al. Immediate Complications After Medical Compared With Surgical Termination of Pregnancy, Obstetrics & Gynecology, 114(4):795-804. NCBI, PubMed. [Online] October 2009. [Cited: September 20, 2011.] http://www.ncbi.nlm.nih.gov/pubmed/19888037. PMID: 19888037.

15. PBS. Frontline, Dangerous Prescription,The FDA: Hazardous to Your Health?, Interview: Paul Seligman, M.D.,M.P.H. PBS.org, WGBH educational foundation. [Online] November 13, 2003. [Cited: August 16, 2011.] http://www.pbs.org/wgbh/pages/frontline/shows/prescription/interviews/seligman.html.

Page Last Updated: 12/02/2011

The Associated Press reported on October 19, 2011 an Oklahoma judge had temporarily blocked from taking effect a new law that requires health care providers to follow the strict guidelines and protocols for medical abortion as it was approved by the U.S. Food and Drug Administration in 2000.

Attorney Michelle Mohaved of the New York-based Center for Reproductive Rights, which is representing the plaintiffs said she was "thrilled" by the ruling as a victory for abortion rights advocates.

However, this is not a victory for the women that are being misinformed of the actual risks of the combined use of the two medical abortion inducing drugs known as mifepristone (RU486) and misoprostol that was approved by the FDA to terminate early pregnancy up to 7 weeks gestation.

These drugs are dangerous and should be used only in strict accordance with FDA guidelines.

Eight American women have died from sepsis (serious infection involving the bloodstream) following medical abortion with mifepristone and misoprostol. These women were instructed to follow various off-label abortion protocols using unapproved/modified regimens that were not recognized by the FDA as being safe and effective.

Four of these deaths included 18-year-old  Holly Patterson, 21-year-old Hoa Thuy "Vivian" Tran, 22-year-old Chanelle Bryant, and 34-year-old Oriane Shevin who each tragically died from a toxic shock infection following medical abortion. These women were instructed by their providers to use an off-label medical abortion regimen that was not approved by the FDA.

Attorney Movahed has disputed the state of Oklahoma's assertion that abortion drugs caused the deaths of these women.

This statement is inaccurate.

According the FDA’s website: FDA has concluded these deaths may possibly be related to the use of these drugs. ⁽¹⁾

Movahed has gone on record and stated the following: “Those cases were investigated by both the FDA and the (Centers for Disease Control and Prevention) and there was absolutely no causal relationship found between those unfortunate deaths and the medications that had been used."

This statement is also inaccurate and misleading.

In 2004 and 2005 , following the death of Holly Patterson and three other young women, the FDA updated the black box warning on mifepristone, trade name Mifeprex, to warn against serious and sometimes fatal infections and bleeding that can occur following medical abortion. The boxed warning states that no causal relationship of these abortion inducing drugs and events have been established.

So how is Attorney Movahed misrepresenting the facts?

First, the FDA would not have placed a boxed warning on the mifepristone abortion drug if there was absolutely no causal relationship found between the women’s deaths and the drugs that were used to terminate early pregnancy.

Second, a drug’s labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established. ⁽²⁾

I am no lawyer, but I can read and understand the facts.

The FDA does not need to establish a causal relationship. It is evident that women are dying from using abortion inducing drugs such as mifepristone and misoprostol. A black box warning, the highest level of possible warnings was added to mifepristone’s labeling at the direction of the FDA.

Finally, a number of so-called evidence-based, alternative, or off-label treatment drug variations have emerged as researchers study other medical abortion regimens that may prove simpler than the FDA-approved approach and may serve a larger number of patients.

This is a major health care concern for women because these unapproved off-label drug uses that circumvent the FDA approval process may have negative public health consequences — including exposing patients to unnecessary risks and destroying the incentive for drug companies to conduct the necessary research to demonstrate that products are safe and effective for these uses.

The FDA-approved medical abortion regimen, an oral combination of 600 mg mifepristone followed 2 days later by office-based administration of 400 mcg of misoprostol, has been used in only 4% of abortion provider facilities since its approval in 2000. ⁽³⁾

The FDA has issued Public Health Advisories (2005, 2006) about sepsis following medical abortion along with a reminder to providers stating the importance of the approved regimen for medical abortion through 49 days’ pregnancy.

The author of the 2011 HB 1970 Oklahoma measure, Republican Rep. Randy Grau of Edmond, should be disappointed with the judge's decision.

It was the wrong decision. Oklahomans are not the only women at risk. This ruling sends a message to all women in the U.S. who are considering medical abortion that unapproved off-label dosing regimens are based on solid scientific evidence and advancements in medicine.

The FDA should not agree with the statements made by Attorney Movahed simply because off-label uses can have potentially negative consequences by undercutting expectations that drug safety and efficacy have been fully evaluated.

Many experts laud abortion inducing drugs as a "safe and effective" alternative to surgical abortion. Medical abortion is an unpredictable and dangerous alternative, especially when providers are not following the FDA approved protocol.

A woman making a medical abortion decision needs to understand the risks, benefits, and options available that is in her best interest of health, safety and welfare.

Women deserve to be told the truth and know the real facts and risks.

For more information: Please visit the website www.abortionpillrisks.org and view the video animation detailing the risks of medical abortion with mifepristone and misoprostol.

References

1. U.S. Department of Health & Human Services. Drugs, Mifeprex Questions and Answers, Question 18, What does FDA know about serious infections reported with Mifeprex use?, 2/24/2010. FDA, U.S. Food and Drug Administration. [Online] February 24, 2010. [Cited: October 21, 2011.]http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111328.htm

2. U.S. Department of Health & Human Services. CFR – Code of Federal Regulations, Labeling, Title 21, Volume 4, 21CFR201.57, (6) 5 Warnings and precautions . (i) General., FDA, U.S Food and Drug Administration. [Online] April 1, 2010. [Cited: October 21, 2011.]http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.57

3. Wiegerinck, Melanie MJ, et al., et al. Medical abortion practices: a survey of National Abortion Federation members in the United States, Contraception, Vol.78, Issue 6. pages 492-499. NCBI, PubMed. [Online] December 2008. http://www.ncbi.nlm.nih.gov/pubmed/19014795

MIFEPRISTONE MEDICAL ABORTION: 11 YEARS LATER

Approved in the U.S. on September 28, 2000, the mifepristone Abortion Pill is claimed to have had an extraordinary journey by abortion providers. Supporters of medical abortion with mifepristone and misoprostol had hoped that it would provide a safe and non-surgical approach to rectify the inequities in abortion care.

Despite the drug’s controversies, while weaving its way through the abortion-related political hazards, medical abortion has made its impact on women. Particularly, the tragic consequences it has had on the lives of many women and their families.

Women are relying upon what they believe is factual information along with a supportive network of providers assuring them of the drug’s safety and effectiveness.

That wasn’t the case for Holly Patterson and many others like her who participated in their own medical abortion procedure.

It is critical that a patient is fully informed of the procedures, administration, and health risks involved with a medical abortion.

After my daughter’s death, 8 years later, the website Abortionpillrisks.org along with what may be the world’s first video on “Medical Abortion with Mifepristone and Misoprostol” has been built to help other women learn about the risk and the facts of the medical abortion pill.

HOLLY’S DEATH: 8 YEARS LATER

After trips to Washington D.C., meeting with officials at the U.S. Food and Drug Administration and the White House, countless interviews with the media, spending thousands of hours researching medical abortion and Clostridium sordellii toxic shock syndrome, much as been learned about what really happened to Holly as well as other women who have been seriously injured or have died.

Holly felt it was important to help other people in life. In her death, much has been learned from Holly’s and other women’s medical abortion experience and it deserves to be shared.

Holly used the internet as source of information to help make a decision about her medical abortion. She did not have all the information she needed to make an informed choice.  If Holly had survived her experience, she may have built a website as a voice to be heard.

“No woman should risk her health or life because she lacks factual and accurate medical abortion information to make a well-informed decision when terminating an early pregnancy with Mifepristone and Misoprostol."

The website, Abortionpillrisks.org – Just the Facts, is a way for women and families to learn about the risks of medical abortion and to be able to share their experiences and stories with others.

Holly did not die in vain.

Sincerely,

Monty L. Patterson

Post Updated: 9/17/2012