Cytotec and the FDA
by Ina May Gaskin

[Editor’s note: This article first appeared in Midwifery Today, Issue 107, Autumn 2013.]

First, a little background information regarding drug safety.

The Food and Drug Administration (FDA) describes its role as serving as a regulatory agency by publishing rules that establish or modify the way it regulates foods, drugs, biologics, cosmetics, radiation-emitting electronic products and medical devices. Much of the prestige that agency still enjoys worldwide stems from the work of Dr. Frances Kelsey, who was a compliance officer at the FDA in the early 1960s. She became an international hero when she withstood great pressure by a prominent German drug company that wanted quick approval for the drug thalidomide to be used for insomnia and morning sickness in pregnant women in the US. The manufacturer insisted that it would be safe for use, pointing out that 20 other countries had already approved the drug. Demanding more testing on the proposed use for pregnant women before she would consider approval, Dr. Kelsey’s insistence on scientific rigor saved countless women in the US from giving birth to children afflicted by phocomelia (missing limbs and other major malformations). Her stubborn stand was vindicated when thousands of babies were born with phocomelia in countries where thalidomide was approved. This tragic development led to the passage of laws by Congress which attempted to strengthen the FDA’s control of drug experimentation on humans and the way new drugs are regulated.

However, now we come to a problem that Dr. Kelsey’s important work did not reach: the practice of prescribing drugs for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration—what is called “off-label use.” Contrary to popular notion, it is legal in the US and in many other countries to use drugs off-label. What most people (including many midwives) may not know is that with the exception of oxytocin and Cervidil, almost all drugs used in obstetrics are prescribed off-label, primarily because there is little or no incentive for a drug company to make an application for a drug intended for pregnant women. This doesn’t mean that there will be no experimentation of drugs on pregnant women. It more likely means that women often won’t be aware that the drug prescribed for them is experimental in nature and that if a drug turns out to have some harmful side effects, these may be very difficult for the public to learn about.

The Story of Two Drugs and Their Obstetric Use

Keeping this background information in mind, it is interesting to compare the medical profession’s and the FDA’s treatment of terbutaline sulfate to stop preterm labor with their treatment of the drug Cytotec (misoprostol) for making labor start or for use with cervical ripening. Both drugs have been used off-label in obstetrics, with terbutaline sulfate having been approved for the treatment of asthma and Cytotec (misoprostol) having been approved to prevent ulcers.

Throughout the 1990s, many studies about both drugs were published in the obstetrical literature. Leading obstetricians, particularly in the US, were clearly interested in gaining the power to stop and start labor at will, with the stated goal of reducing or eliminating fetal deaths related to pre- or postterm labor. During this period, millions of women were given these drugs, many of them without being informed that they and their babies were subjects of experiments in new, possibly risky therapies.

The first dark cloud that appeared over the use of terbutaline sulfate came in 1993, with the publication of a case report of a maternal death attributed to terbutaline (Hudgens and Conradi 1993). The report described a 34-year-old previously healthy first-time mother, pregnant with twins, who began to be treated with terbutaline at 25 weeks. A week after the therapy was begun, first in hospital and then continued with a subcutaneous infusion pump at home, her husband found her unresponsive in her bed still attached to the pump. She had been dead for some time. The paper’s author remarked that this case hadn’t been the first maternal death associated with the drug—just the first one that had taken place at home.

In 1997, the FDA issued a “Dear Colleague” letter warning health professionals that the precautions section of its labeling for terbutaline sulfate had been revised to warn about heart attacks in women, especially those whose treatment with the drug lasted more than a couple of days. Several studies were then published in the medical literature that corroborated the FDA’s concerns. Despite these labeling changes and medical reports, terbutaline continued to be prescribed by some obstetricians for prolonged use.

In February 2011, the FDA issued a sterner warning on its website against the use of terbutaline for preterm labor, stating that 12 maternal cases of serious cardiovascular events had taken place between its “Dear Colleague” letter and July 2009. In this case, the FDA’s warning was considered noteworthy enough to warrant an article in USA Today, providing a wider public exposure to the FDA message than that afforded by its postings on its website.

One thing should be noted: although it’s obvious that many physicians ignored the FDA’s warnings to discontinue use of terbutaline to ward off preterm labor, no campaign was ever waged by the American College of Obstetricians and Gynecologists (ACOG) to pressure the FDA or to muddy the waters about the risks of using the drug in pregnant women. The FDA was thus free to issue a press release that increased the chance that its warning on the website would actually reach some of the public. What happened in the case of Cytotec/misoprostol is quite different and more complicated.

The Case of Cytotec/Misoprostol for Induction

As early as 2000, G.D. Searle, the original manufacturer of Cytotec, had already received reports of a long list of adverse effects from use of the drug for induction of labor. We know this because the company issued a letter in August of that year addressed to all birth professionals, urging them never to use it for induction because of the danger of maternal or fetal death, uterine hyperstimulation or salpingo-oophorectomy, amniotic fluid embolism, severe vaginal bleeding, retained placenta, shock, fetal bradycardia and severe pelvic pain.

It was already possible to read in the medical literature that Cytotec often hyperstimulated the uterus (Wing et al. 1995; Gotschall et al. 1997), increased the incidence of thick meconium being passed (Wing et al. 1995; Mundle and Young 1996; Surbek et al. 1997), caused prolonged contractions in some women more than 20 hours after the last dose (Wing et al. 1995), was sometimes associated with more third- and fourth-degree lacerations than with other induction drugs (Mundle and Young 1996), caused massive postpartum hemorrhage that couldn’t be stopped without hysterectomy (Wing and Paul 1996), was associated with a maternal death from amniotic embolism (Wing and Paul 1996; Perry et al. 1998), could rupture an unscarred uterus even with a minimal or moderate dose (Bennett 1997; Khabbaz et al. 2001), caused fetal distress (Toppozada et al. 1996), was associated with a high incidence of babies sent to the neonatal intensive care unit (Wing and Paul 1998; Perry et al. 1998), and was associated with high cesarean rates (Gotschall et al. 1997). Even so, Cytotec’s popularity with many obstetricians was already well established, despite the still experimental status of the drug and the manufacturer’s warning.

Two months after the release of the Searle letter, ACOG sent a letter to the FDA and a press release to the media, insisting that any adverse effects that had been reported to the FDA or to Searle had been the result of incorrect use of Cytotec and after another month, ACOG requested, in what it called a “citizen petition,” that the FDA require that Searle retract its warning letter. The FDA has so far declined to fulfill this request.

In contrast to the relatively clear information provided the FDA with regard to the number of maternal deaths reported in connection with terbutaline use, the FDA’s adverse events reports on Cytotec “reactions” are less clear. In a report covering the period between November 1, 1997, and September 30, 2005, we can learn that 19 cases of amniotic fluid embolism were associated with Cytotec induction. Usually, this complication is fatal to the mother and often to the baby as well, but unless the FDA decides to tell us more, we have no answer to the question of how many mothers and babies actually died. The same goes for the 50 uterine ruptures reported during the same period. Ruptures are sometimes fatal and sometimes result in hysterectomy, but these details are not quantified in the list of adverse events related to Cytotec induction.

To date, two maternal deaths have been mentioned in the medical literature following Cytotec induction (Wing and Paul 1996; Agüero 1996). In the case of a Venezuelan mother, the woman’s death from amniotic fluid embolism after induction with Cytotec escaped notice in the English-speaking world because the report was published in Spanish. In the case of the 1996 Wing study in Los Angeles, the authors write that the maternal death from amniotic fluid embolism should probably not be directly attributed to Cytotec because the crisis took place nine hours after the last dose and because two other interventions took place as well (intrauterine pressure catheter and amnioinfusion). However, Wing herself had already commented in 1995 that “[S]ome patients appear to be quite sensitive to misoprostol, demonstrating prolonged contraction responses after a dose of the agent, sometimes in excess of 20 hours after the drug” (Wing et al. 1995). It seems quite possible that this mother could have been one of those sensitive ones. Given that the drug was experimental and that all the previous studies had involved small numbers of women and involved quite different study designs, doses, dose intervals and ways of administration, the drug should not be regarded as innocent until proven guilty. Secondly, the point that is missed is that the intrauterine pressure catheter and the amnioinfusion (which can also cause amniotic fluid embolism) almost certainly were made necessary by the Cytotec induction itself.

In that same Wing study (Wing and Paul 1996), we find two cases of maternal near-deaths mentioned in the last pages of the article, both due to uterine atony following birth. Each of these first-time mothers had also been given a single 25 mcg dose of Cytotec and both required emergency vaginal hysterectomies to save their lives. In spite of the three adverse outcomes, Wing and colleagues still concluded: “These results demonstrate that misoprostol therapy is efficacious and, within the limited scope of this study, safe.”

A case report about still another maternal near-death should be mentioned with regard to Cytotec induction (Sachs 2005). This paper was so unusual that The Boston Globe called it a “remarkable example of public disclosure” (Kowalczyk 2005). A “Mrs. W.” was healthy and had just reached 41 weeks of her first pregnancy in 2000. Her obstetrician decided to admit her to the hospital for induction on a busy night despite the fact that he or she was not on call. With blood pressure at 125/90, Mrs. W. was given a 25 mcg dose of Cytotec vaginally and sent home. On the way, her contractions began rapidly and close together, so she returned to the hospital. By this time, she was vomiting and her blood pressure had risen sharply to 174/104, with her cervix still closed. Within an hour, her contractions were coming every one to two minutes. There followed an epidural, an episode of very low blood pressure, late decelerations of the heart rate, an attempt at forceps delivery and an emergency cesarean. Both baby and placenta were found loose in her abdominal cavity, the baby stillborn. Mrs. W. suffered prolonged disseminated intravascular coagulopathy, hysterectomy, acute respiratory distress syndrome, sepsis and wound infection, and three years later was still not fully recovered.

In his JAMA article, Dr. Benjamin Sachs, department chair of Beth Israel Deaconess Medical Center, acknowledged that the case involved “numerous failures in terms of communication and planning, including four errors in judgment,” as well as six system failures (Sachs 2005, 833). However, we might wonder why the decision to prescribe Cytotec in the first place was not mentioned among them, nor was the lack of explanation of the risks associated with administering Cytotec for an unapproved use.

Mrs. W. made a comment in the JAMA article about her ordeal: “The drug that was used was a sort of quick method of bringing labor on, without my knowledge. And unfortunately, knowing that after was troublesome to me. The risks of that drug were not indicated to me” (Ibid).

Mr. W. asked a question that went without a clear answer: “How are mothers, patients, being informed of the use of misoprostol, or any drug that may be used on them? You know that it is important to make the ultimate decision as a patient. The only way to do that is with knowledge” (Ibid).

Mrs. W.’s doctor’s comment related to this was: “I reviewed with Mrs. W. that the risk of an induction is that it might fail and necessitate a cesarean delivery. However, as misoprostol is viewed as a safe medication, I did not discuss any specific complications” (Ibid). Unfortunately, this failure to inform mothers of the risks is still common.

Most but not all of the earlier Cytotec studies involved women who were not trying for a vaginal birth after cesarean (VBAC). In 1998, two papers appeared in the English-language medical literature. One was a case report published in a journal for Australian and New Zealand obstetricians which appeared with this editorial comment: “It is our understanding that a number of trials of misoprostol for induction of labour include patients with a prior Caesarean section which is a further reason for heeding this case report. In the past 40 years or so the introduction of each new oxytocic agent to induce labour, whatever the route of administration, ranging from intramuscular, intravenous, sublingual, intranasal spray, intraamniotic, extraamniotic, vaginal and oral has subsequently been followed by reports of rupture of the uterus. It would seem that misoprostol is no exception to former preparations” (Sciscione et al. 1998).

That same year saw the publication of another paper by Dr. Wing and associates, announcing the cancellation of a study comparing oxytocin induction with Cytotec/misoprostol induction for women wanting to give birth vaginally after a previous cesarean. The cancellation decision was made after only 38 women had started labor, because 2 of 17 women in the misoprostol induction arm had large uterine ruptures (Lovett et al. 1998). More articles detailing more ruptures appeared on the subject, essentially forcing ACOG to declare some policy position other than a blanket defense of the experimental use of Cytotec/misoprostol (Blanchette et al. 1999; Hill et al. 2000; Plaut et al. 1999). At this point, ACOG published recommendations for labor induction stipulating that Cytotec should not be used on women having VBACs. However, the language regarding the effect of Cytotec on women who had not had prior uterine surgery stated only that the drug was effective for cervical ripening and induction of labor, leaving the question of its safety open (ACOG 1999). Because of this ambiguity, many obstetricians, as well as some midwives, seem to think that the ACOG bulletin “constitutes a recommendation by ACOG of the use of Cytotec for induction with no previous c-section” (Wagner 2006). Several obstetricians have stated that they were taught that Cytotec is safe for conditions that are clearly contraindicated on the label.

The Cochrane Library in 2010 reiterated its position on the safety of misoprostol: “Information on women’s views is conspicuously lacking…. The studies reviewed were not large enough to exclude the possibility of rare but serious adverse events, particularly uterine rupture, which has been reported anecdotally following misoprostol use in women with and without previous caesarean section. The authors request information on cases of uterine rupture known to readers” (Hofmeyr and Gulmezoglu 2003).

How Are Women Being Informed about the Risks of Cytotec/Misoprostol for Labor Induction?

In an effort to protect women, Maddy Oden, who lost a daughter and granddaughter to two doses of Cytotec, began the Tatia Oden French Memorial Foundation which has petitioned the FDA to do a better job of warning the public about the risks of Cytotec for labor induction. After several years of effort and numerous meetings with FDA officials, the FDA came to a position in November 2012, which can be summed up as follows: While denying ACOG’s request that the Searle letter be retracted, the FDA writes, “We believe that health care providers are in the best position to educate and counsel patients about the risks and benefits of labor induction as they pertain to the individual patient.”

The FDA has stated that its 2005 Alert is sufficient for protecting pregnant women against the risks associated with Cytotec/misoprostol and has thus declined the requests made that would make it easier for women whose doctors might prescribe Cytotec for induction to get some idea of how many people have already had suffered adverse effects from this use (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111315.htm).

At the same time, the FDA states that this position is still preliminary and subject to further review and so provides this link for its MedWatch program: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

Will the blogosphere become the default for better information about the risks of Cytotec induction? Judging by the number of maternal deaths that have been reported to the team at the Safe Motherhood Quilt Project (14, to date), we are not likely to see a case report in US literature linking a maternal death to Cytotec induction of cervical ripening. Such case reports may have ended in the early 1990s.

However, a new study on Cytotec about a new way to deliver the drug vaginally is scheduled for publication soon, according to a report dated February 19, 2013, in MedPage Today. In this case, misoprostol would be delivered via a suppository instead of bits of a halved or quartered tablet. The researcher, Dr. Wing (the same one who carried out so many other small studies), stated that more drug-related adverse events occurred in the women whose labors were induced with misoprostol than with the Cervidil vaginal insert (which is FDA-approved). However, Wing was reported to have said that the misoprostol worked faster and that it was associated with “faster delivery of any type,” whether that was vaginal or cesarean birth. Wing predicted that the new method would be adopted by other obstetricians since it was easier to give—even though it is more expensive than the misoprostol pill. She maintained this confidence even though the misoprostol-related adverse effect rate during labor was 13% compared with 4% for the Cervidil inductions in the study.

At the end of the article, we are told that the new study was sponsored by a drug company: Ferring Pharmaceuticals (formerly Cytokine), that two of Wing’s co-authors were employees of Ferring Pharmaceuticals and that Wing herself reported consulting for Ferring Pharmaceuticals.

Cytotec Victims Speak Out

The following comments were taken from an online petition against the use of Cytotec. If you haven’t signed the petition, please do so and give your thoughts on this drug. PetitionOnline.com/cytotec/petition.html.

I lost my daughter to this drug!

My daughter was given Cytotec to induce labor. She was not warned of the adverse effects. She now suffers from much pain caused by the horrific pressure put on her brain from having one long contraction that wouldn’t end, with the urge to push. She is on heavy medication for the pain and her two daughters now have a mom that isn’t able to be the mom she was before the second baby was born. I pray that OBs and midwives will not have access to this drug that has already caused the deaths of so many mothers and their babies.

I used Cytotec in labor; my daughter had a seizure the day after.

My son died as a result of my uterus literally blowing up during the last phase of pushing.

I held my son in my arms while he was taken off life support thanks to Cytotec.

Cytotec almost killed me during labor.

The drug caused terrible complications for my daughter and could have caused her death.

My daughter was left disabled after the use of Cytotec to induce labor. My labor was too quick and caused her to be without oxygen. She died seven months and five days later due to the damage on her brain on Christmas Day, 2002. I have suffered very badly due to trusting that this drug would be safe to use. Instead I have to live with the pain of one terrible choice for the rest of my life.

In memory of my daughter who died after I received three doses of this horrible drug. I trusted my OB and would never have allowed the use of Cytotec had I known its fatal side effects.

Due to Cytotec, my uterus completely blew up and tore in all directions. My daughter was thrown into my abdomen and was cut off from oxygen. My beautiful daughter has cerebral palsy and seizures. Cytotec should not be used to induce pregnant women. Cytotec was designed to aid digestion for gastric ulcers. Now this drug has moved on as an “off-label” drug to combine with the RU486 drug to complete abortions. Doctors are led to believe that this off-label drug can aid in ripening a woman’s cervix even though Searle, its manufacturer, warns against its use on pregnant women. Cytotec is a political pill that is hard to swallow! Please act now and ban this drug from being used on full-term pregnant women before we lose yet another beautiful mother and baby.

I watched my wife almost bleed to death after her uterus ruptured. Please stop this!

This drug is dangerous and should never be used for labor induction. My friend almost bled to death due to administration of this drug without being told of the contraindications!

My daughter and granddaughter almost died.

My wife and daughter both almost died due to the use of labor induction drugs.

I was given Cytotec without knowing any of the side effects. Luckily my child and I lived, but my uterus did tear at the lowest segment into my cervix. My OB lied to me and I recently found out and I am very upset. I later found out that a young lady died by the hands of this doctor one week after I gave birth to my daughter. We have got to do something about this. A mother and her daughter died a senseless death and the manufacturer of these drugs and the doctors using these drugs need to be penalized and some form of punishment needs to take place. I am so very, very angry! They are taking our rights of empowerment away for their own benefits. I am sickened by this and these doctors need to lose their license as well.

My friend’s uterus ruptured and the baby died due to Cytotec.

I believe I was given Cytotec. I went to the hospital at 10 am and by 5 pm I had a ruptured uterus and a dying baby. I lost three or four pints of blood. I almost died and the next day my perfect darling child died because my doctor had a tee time he did not want to miss. I am broken-hearted. I came home from the hospital two weeks later with empty arms. The nine months I waited for my baby was for nothing. I never even got to see her face. Empty arms and a broken heart—so uncalled for. I understand the sorrow of all the poor women who have suffered as I have. I hope there is more control over the use of this dangerous drug. God bless all the broken-hearted mothers who have gone through what I have gone through.

I witnessed a labor during which this product was utilized and I feel that there is not enough info provided to consumers. In fact this woman was told not to tell anyone or the hospital could be in trouble. This is not right. The labor was not helped by using this product either and ended in a cesarean. Breastfeeding could not be initiated and bonding was not what it could have been. I do not see any advantage in this product’s use and in fact I felt that it was a detriment ultimately. I am a postpartum doula trainee with CAPPA.

I had uterine hyperstimulation and fetal oxygen deprivation from this tiny pill my nurse promised was generic Cervidil. How many more women and babies will suffer before the FDA does its job and protects consumers from the unscrupulous use of dangerous drugs?

I was given this drug to induce labor because my daughter was “getting too big.” This was my first child and I trusted my doctor. He did not tell me about any side effects of this drug. My daughter was born perfectly healthy, but I almost bled to death and had to have a hysterectomy.

Please do something about this injustice. “Everyone else is using it” is not an excuse. It caused debilitating and permanent injuries to my wife with a previous unscarred uterus.

Cytotec was the first step on my road to a cesarean!

I was given this drug for the birth of my son in 1999. I had no idea of anything negative associated with this drug. This drug caused hyperstimulation of the uterus and I thought that I was going to die because of the unbearable pain. I’m thankful for our health, but angry that this drug was used without proper testing/approval.

I was given Cytotec and almost lost my baby and my life.

In memory of my son born February 2, 2005, and died on February 9, 2005, after I was given Cytotec to induce my labor but was not told or warned in any way.

One of my friends was forced to have an emergency hysterectomy after an amniotic fluid embolism as a result of Cytotec. She nearly died in labor. This drug should be banned for use in the induction of live births.

In 2002 I was given Cytotec to induce labor and ended up nearly dying. I had to have an emergency hysterectomy and spent several days in the ICU. This was my first child and I was only 26. I am thankful every day that my son was born healthy! The diagnosis was amniotic fluid embolism, but I was not told that Cytotec was most likely the culprit.

My niece had a ruptured uterus from this medication and had to have a hysterectomy after delivering her son by an emergency cesarean. We were lucky we didn’t lose both of them during this emergency! Because of this, they can’t have any more children!

A friend of mine required over 25 units of blood after getting this medication—she and the baby almost died.

The doctors gave us none to very little hope after my sister was life-flighted to another hospital to treat her critical condition from the effects of having her labor induced with Cytotec.

My baby died three weeks ago because of this drug. I almost died too. I had a uterine rupture.

My son had a hemorrhage in his brain due to Cytotec.

A personal friend lost a baby due to this drug.

My child died as a result of a cervical-ripening agent. He was a beautiful 9 lb 5 oz baby. He had a good strong heartbeat up until the drug was given.

My nephew has cerebral palsy due to the use of Cytotec to induce labor.

I suffered a severe uterine rupture, had to have an emergency hysterectomy and almost died. I didn’t know the side effect of this drug when given. Thank God my baby is healthy.

My grandson died because of Cytotec. I nearly lost my daughter as well. The attending physician never told my daughter that he was giving her this dangerous drug. After my grandson was delivered brain dead, the doctor remained quiet about the part he played in this tragedy. We learned after it was too late about Cytotec and the part it played in Andrew’s death. It was months later that we learned to our surprise and horror that doctors can use a drug any way they want to once the drug has been approved by the FDA for some other purpose. Had my daughter been informed of what she was being given and the possible consequences, she never would have taken Cytotec and our grandson would be alive today.

I lost my precious baby at two weeks in 2005 after a Cytotec induction gone wrong I nearly lost my own life.

I had amniotic fluid embolism after receiving Cytotec in 2002.

In 2006 I was given Cytotec without my knowledge during labor and nearly died.

I was given this with my son in 2001. We almost lost him and had many months of health issues related to this drug. I was not informed about any side effects.

I never would have allowed the use of Cytotec to induce my labor had I known all the risks associated with it. This drug led to a hysterectomy after the birth of my only child, a stillborn daughter. I am only 25 years old.

I just lost my granddaughter due to hyperstimulation caused by Cytotec.

My wife died one hour after giving birth on November 4, 2004.

I was induced with two doses of Cytotec in conjunction with Cervidil and experienced uterine rupture. My son was without oxygen for seven minutes and has cerebral palsy. I was told I must have had a congenital defect—you can draw your own conclusions. I sincerely hope this never happens to another mother and child.

My friend just lost her baby girl to Cytotec. The mom almost died and spent a week in the hospital fighting for her life. She can no longer have children.

An extremely high dose of Cytotec was administered without my knowledge and informed consent. As a result my baby was aborted and I could have died as well.

My sister died April 22, 2008, from an amniotic fluid embolism after receiving Cytotec. Her name was Wendy and she was a beautiful person.

I was given this drug and had severe bleeding and blood clots during labor. When asked why all the bleeding was happening, their reply was, “I don’t know.” My son had aspirated on my blood. He didn’t cry—he was limp and dazed. He was quickly taken from me and put in the NICU. He was given antibiotics and hooked up to many machines including an IV. He stayed in the incubator for over 24 hours. He got a little better then got worse. They did X-rays of his chest and tests, which we thought to be blood tests to rule out infection. After three days we went home together. This, by the way, was my fifth baby and my first time ever having Cytotec. Thank you for letting people share a little something.

We nearly lost our daughter and granddaughter in 2001 from the misuse of Cytotec. Our daughter was never told of the dangers of using Cytotec for induction of labor. She had Cytotec inserted in her vagina after about five hours into the induction. During the labor process the doctors changed shifts. Her regular doctor came on the scene at that time and knew of the dangers of Cytotec with previous uterine surgeries. (The first doctor inserted the Cytotec. Our daughter had a tumor removed from the back of her uterus in 1993 and several procedures done to her cervix.) After several hours of very hard labor, the delivery began. Our daughter had hard, heavy bleeding with very large blood clots, her uterus ruptured and her first-born child, a girl, was not breathing! Our granddaughter spent thirteen days in the NICU hooked up to tubes, wires and monitors. She came home with a feeding tube and a monitor that would alert us if she stopped breathing. After several months, our granddaughter was diagnosed with cerebral palsy and epilepsy. She was denied oxygen during her birth. She is now six years old and is very beautiful. She has big brown eyes, natural curly blonde hair and a smile that will melt your heart!

Cytotec almost killed my friend.

My wife was given Cytotec to induce labor and had adverse effects from it.

I nearly died at the Mayo Clinic after being dosed most emphatically against my will.

I just had a baby five weeks ago. Cytotec caused hyperstimulation of my uterus causing my baby’s heart to drop down to the 60s. I was given Cytotec at 8:45 and was scheduled for an emergency c-section but I delivered too quickly at 10:00. How can we stop the use of this drug to induce labor? Please do something quickly before more babies and women die. Please, please, please!

When I was induced eight months ago for a postdate pregnancy, I was asked to sign a blanket consent for induction prior. I had no idea that the drug I was being induced with was being used not just “off-label,” but actually “against-label”! I would have never consented to administration of a drug that specifically states that it is not to be used for induction. I had contractions coming too quickly and my baby was having heart rate problems with decelerations. I was horrified to learn the facts about misoprostol six months after it was used on me, and I am very thankful that my baby girl and I are both okay. I am so sorry for those who were not so lucky. Please do something to end the against-label-use of this ulcer drug.

References:

  • ACOG. 1999. “Induction of Labor.” Practice Bulletin Number 10.
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  • Blanchette, H, et al. 1999. “Comparison of the Safety and Efficacy of Intravaginal Misoprostol (Prostaglandin E1) with Those of Dinoprostone (Prostaglandin E2) for Cervical Ripening and Induction of Labor in a Community Hospital.” Am J Obstet Gynecol 180:1551–59.
  • Gotschall, DS, et al. 1997. “A Randomized Clinical Trial Comparing Misoprostol with Prostaglandin E2 Gel for Preinduction Cervical Ripening.” Am J Obstet Gynecol 177:1067–70.
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  • Kowalczyk, L. 2005. “A Baby’s Death Prompts Reforms in Care.” The Boston Globe. Accessed July 30, 2013. boston.com/yourlife/health/children/articles/2005/08/17/a_babys_death_prompts_reforms_in_care/.
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  • Plaut, M, et al. 1999. “Uterine Rupture Associated with the Use of Misoprostol in the Gravid Patient with a Previous Cesarean Section.” Am J Obstet Gynecol 180:1535–40.
  • Sachs, B. 2005. “A 38-year-old Woman with Fetal Loss and Hysterectomy.” JAMA 294:833–40.
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Ina May Gaskin is the founder and director of The Farm Midwifery Center in Tennessee. She is the author of Spiritual Midwifery (1975) and Ina May’s Guide to Childbirth (2003). She was president of MANA from 1996–2002, and is a prominent national and international speaker. She has been a homebirth midwife since 1971.


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