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Natural Birth
flyer23
member
Cytotec
flyer23
member
In the post on inductions a few days ago, a lot of people said that they'd never consent to the use of Cytotec, because it's dangerous.
I know Cytotec has a terrible reputation in the natural birthing community, but I think it's important to get the facts straight. If you do a web search, you'll easily come up with plenty of concerns around Cytotec. Most of them boil down to the following:
1. Cytotec is not FDA-approved for the induction of labor. It's an "off-label" usage.
2. There have been reports of uterine rupture after using Cytotec to induce labor.
3. Due to #1 and #2, the former manufacturer of Cytotec sent a letter to doctors back in 2000, warning them against the use of Cytotec to induce labor.
All of these things are 100% true, but they are not the full story.
#1: It is true that Cytotec is not FDA-approved for the induction of labor, but doctors prescribe drugs off-label all the time. Just to give an example, I have prescriptions right now for Prometrium, to combat low progesterone that could cause me to miscarry, and Zofran, in case the Prometrium makes me nauseous. Prometrium is FDA-approved for hormone replacement therapy in women going through menopause and Zofran is FDA-approved to help alleviate nausea in patients going through chemo. Neither is FDA-approved for use during pregnancy, yet both are regularly prescribed for pregnant women. Cytotec is also commonly prescribed in the case of a missed miscarriage to force the body to expel the fetus; this is also an off-label use of this drug (but one that meets with far less criticism).
Of course, this doesn't mean that ALL off-label prescriptions are safe, but it does mean that off-label prescriptions are NOT inherently unsafe.
#2: The reports of uterine rupture with Cytotec were with women attempting a VBAC. Certainly, Cytotec should never ever EVER be used to induce labor in patients who have had prior uterine surgery, and indeed, many providers refuse to induce these types of patients at all (even with Cervidil or Pitocin). But for women without prior uterine surgery, the risk of uterine rupture with Cytotec is similar to what it is during a spontaneous labor.
#3: The August 2000 letter from Searle was mostly CYA, after the reports of uterine rupture in VBAC patients were reported, to remind physicians that Searle wouldn't take any responsibility for negative side effects of off-label use of its drugs. Again, this doesn't mean that the off-label use was inherently unsafe.
On the flip side, Cytotec has been shown to be more effective than Cervidil. Women who receive Cytotec are more likely to deliver vaginally and avoid other interventions. So there are some very valid reasons for a provider or a pregnant woman to prefer Cytotec.
All that said... personally, when I was facing induction, I specifically asked to start with Cervidil and then move to Pitocin. I preferred to avoid Cytotec if I could help it. One thing that does concern me about it is that it's a pill that you either take orally or insert vaginally. If it does cause uterine hyperstimulation, you can't just take it out (like you can with Cervidil) or turn it off (like you can with Pitocin). So, it's my personal induction method of last resort. That said, if I needed to be induced and Cervidil/Pitocin weren't cutting it, I'd consent to Cytotec in a heartbeat vs. going in for a c-section.
As always, informed consent is absolutely key, and that means being informed of both the benefits and the risks. Unfortunately, many women who listen only to their doctors, or only to natural birth advocates, only get one side of the story.
Mommy to DD1 (June 2007), DS (January 2010), DD2 (July 2012), and The Next One (EDD 3/31/2015)
This discussion has been closed.
Re: Cytotec
Someone posted the other day (I think on the third trimester) about the cost difference between Cytotec and Cervidil and it was literally over $100 difference (Cytotec being the less expensive option)
Just knowing that makes me wonder if the frequent use of Cytotec is really because it is the more effective option or if it is just the less expensive option. ::shrugs::
Maybe it's both. Here are three recent studies comparing Cytotec to Cervidil and they all find that Cytotec is more effective without increasing complications. Better efficacy + way less expensive sounds like smart medicine to me. If we natural birth advocates are serious about giving women information to make their own choices, about evidence-based medicine, and about lowering cesarean rates, then why does Cytotec get demonized so much?
https://www.sciencedirect.com/science/article/pii/S0002937810003121
Results
Women who received misoprostol had a higher incidence of vaginal delivery within 12 and 24 hours of prostaglandin application, compared with dinoprostone. Both modalities had similar incidences of cesarean delivery, uterine hyperstimulation, and fetal tachysystole. There was an increased need for oxytocin augmentation in the dinoprostone group. No significant difference in neonatal outcomes was noted between the 2 groups.
Conclusion
Vaginally administered misoprostol was more effective than the dinoprostone vaginal insert for cervical ripening and labor induction. The safety profiles of both drugs were similar.
https://journals.lww.com/greenjournal/Abstract/2009/02000/Low_Dose_Oral_Misoprostol_for_Induction_of_Labor_.20.aspx
The five trials comparing oral misoprostol and dinoprostone showed significantly fewer women requiring cesarean delivery in the misoprostol group (20% compared with 26%; RR 0.82, 95% CI 0.71?0.96). There were no statistically significant differences in risks of uterine hyperstimulation or need for oxytocin augmentation. Two trials compared oral with vaginal low-dose misoprostol. Women using oral misoprostol were significantly less likely to experience uterine hyperstimulation with fetal heart rate changes (2% compared with 13%; RR 0.19, 95% CI 0.08?0.46), but there were no significant differences in other outcomes.
CONCLUSION: Low-dose oral misoprostol solution (20 micrograms) administered every 2 hours seems at least as effective as both vaginal dinoprostone and vaginal misoprostol, with lower rates of cesarean delivery and uterine hyperstimulation, respectively.
https://www.ncbi.nlm.nih.gov/pubmed/21780543
Induction to vaginal delivery interval was significantly lower (p < 0.05) for 50 microg (13.8 +/- 6.62 hours) as compared to 25 microg misoprostol (16.4 +/- 7.34 hours) or dinoprostone group (16.3 +/- 7.49 hours). Maximum improvement (p < 0.05) in Bishop's score and minimum oxytocin requirement (p < 0.05) was seen with misoprostol 50 microg. No significant difference was observed for women delivering vaginally within 24 hours (93.8 vs. 89.7 vs. 85.4%), patients delivering after one dose (24.3 vs. 21.4 vs. 20%), cesarean deliveries, fetal outcome, complications like hyperstimulation and fetal heart abnormalities for the 50 vs. 25 microg misoprostol vs. dinoprostone group.
CONCLUSION:
Intravaginal misoprostol 50 microg administered 6 hourly appears to be most effective as it has least induction to delivery time, has maximum improvement in Bishop's score, least oxytocin requirement without any increase in complication rate.
I'm really glad to see this post. I also read quite a few negative things on this board in recent days, and wanted to say something (particularly regarding rupture) but never found the time. Cytotec can be useful in certain, limited circumstances. The same applies to many other interventions. It is more of a matter of a skilled provider being able to provide the patient with the proper information, so that the patient can then weigh the possible outcomes and give truly informed consent.
One thing that I find very interesting is that misuse of cytotec for VBACs has given fodder to both the natural birth community and those who want to limit VBACs. Both sides see the same data, but one side chooses to blame the VBAC, while the other blames the cytotec.
Mommy to DD1 (June 2007), DS (January 2010), DD2 (July 2012), and The Next One (EDD 3/31/2015)
I'm a Cervidil success story, too -- I did need Pitocin as well, but the combination was perfectly effective for me and I delivered DD vaginally with no complications.
But it was good to know that Cytotec was an option if Cervidil and Pitocin weren't effective, and I think it's totally fine to provide women with that option, as long as truly informed consent is given. (I'm well aware that it's often not.)
As for reasons why it's not approved for use during pregnancy, I believe it's very rare for drugs to get that type of approval. (Cervidil and Pitocin are two exceptions to that rule.) The reason being that it's hard/impossible to prove that something is 100% safe, and the risk of legal action is incredibly high when it comes to pregnancy-related stuff. The Bendectin case is a classic example: https://www.nytimes.com/1983/06/19/weekinreview/shadow-of-doubt-wipes-out-bendectin.html
Getting approval is really high-risk/low-reward for the drug manufacturer... if they were to pursue FDA approval for use of Cytotec to induce labor, they'd have to spend a lot of money doing trials, etc., AND open themselves up to a lot of liability if safety concerns ever do arise. By NOT pursuing FDA approval, they still get the benefit of many many many OBs using it for that purpose, without the liability issues. Bottom line, the lack of FDA approval really has little to do with the safety or the effectiveness of using the drug for that purpose; it's all about liability.
Mommy to DD1 (June 2007), DS (January 2010), DD2 (July 2012), and The Next One (EDD 3/31/2015)
Thanks for posting this. Just a question- the study above is based on using a low dose over a certain amount of time, correct? Is that the way it is implemented universally? I am assuming that since it was created for another use, it probably does not come with specific instructions...or is the study above the instructions?
Also, I was wonder what is your take on the response posted after mine (the L&D nurse who said it was harder to stop than Cervidil)?
Thanks for indulging me- I learn so much from these boards!
That's an excellent question. I think it probably is not universal, and that is definitely one of the downsides to Cytotec IMO. I think the L&D nurse also makes a valid point. So those are things that should be considered when weighing induction options.
My issue is just when people say "OMG run far away from Cytotec!!" I don't think that is helpful.
Agreed 100%. I specifically said in my initial post that personally, when faced with induction, I told my OB that I wanted to start with Cervidil, precisely due to the difficulty of "stopping" Cytotec if it proved too effective.
But I think saying "OMG run far away from Cytotec!!" is just as unhelpful and, frankly, downright misleading as OBs who use it without informed consent.
And the whole low-dose thing is less an issue of FDA approval vs. off-label usage, and more an issue of provider knowledge/patience levels/etc. The exact same thing is true of Pitocin (which IS FDA-approved for labor induction), in that some providers choose to follow a high-dose regimine that does increase the effectiveness as well as the risk of hyperstimulation/rupture/fetal distress/other Bad Stuff. But I should probably save that discussion for a separate post
(If you can't tell, having been through a wonderful induction experience, I have a LOT of pet peeves around the natural birth community's treatment of induction...)
At any rate, THAT type of thing is precisely why we need to have these discussions. So that if someone IS faced with a Cytotec induction, or a Pitocin induction, for completely valid reasons (because they DO exist), she's educated enough to ask her provider, "Hey, what dosage will you use?" That question right there can mean the difference between a safe, successful birth and an emergency c-section due to uterine hyperstimulation.
Mommy to DD1 (June 2007), DS (January 2010), DD2 (July 2012), and The Next One (EDD 3/31/2015)
Good point about different dosages being used for Pitocin too.
This is from the Cytotec Offical FDA information page (basically what would be with the medication). For me, personally, if there is a big warning on a label that it should be used when you're pregnant, then I'm not going to use it and I think it's dangerous for doctors to use it without having the mother look over all this information as well (or the father if the mother isn't in the position to read it).
Warnings
Cytotec (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN Cytotec WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY (see also PRECAUTIONS and LABOR AND DELIVERY). Cytotec SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs) (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).
Cytotec can induce or augment uterine contractions. Vaginal administration of Cytotec, outside of its approved indication, has been used as a cervical ripening agent, for the induction of labor and for treatment of serious postpartum hemorrhage in the presence of uterine atony. A major adverse effect of the obstetrical use of Cytotec is the hyperstimulation of the uterus which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), or amniotic fluid embolism. Pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported.
There may be an increased risk of uterine tachysystole, uterine rupture, meconium passage, meconium staining of amniotic fluid, and Cesarean delivery due to uterine hyperstimulation with the use of higher doses of Cytotec, including the manufactured 100 mcg tablet. The risk of uterine rupture increases with advancing gestational ages and with prior uterine surgery, including Cesarean delivery. Grand multiparity also appears to be a risk factor for uterine rupture.
The effect of Cytotec on later growth, development, and functional maturation of the child when Cytotec is used for cervical ripening or induction of labor has not been established. Information on Cytotec's effect on the need for forceps delivery or other intervention is unknown.
Well, yeah. Misoprostol is an abortifacient. It is one of the drugs used in RU-486. There better be a big fvcking warning on the packaging.
That doesn't mean it is dangerous to use for inductions. The very properties that make it an effect abortion drug also make it effective for inductions and for treating PPH. If multiple studies show it poses no more risk than Cervidil, what is the problem? The section I bolded is also true of Cervidil and Pitocin. Does that mean no one should ever be induced?
So are you saying that that if you were me, you would stop taking Prometrium? After all, this is what the official FDA information says about it:
But given that my progesterone levels are less than half of what they should be, and given that I've already suffered through the heartbreak of a miscarriage that was likely due to low progesterone when I was NOT taking Prometrium... I'll take my chances with the medicine with the big warning on it that says it shouldn't be used during pregnancy, thank you very much.
Once again. Off-label uses of medications are very common. They are not inherently unsafe. Cytotec is no different from Prometrium or any other drug in this respect.
Mommy to DD1 (June 2007), DS (January 2010), DD2 (July 2012), and The Next One (EDD 3/31/2015)
The reasons I feel Misoprostol (cytotec, miso) is riskier than cervadil:
My doc has been very open with me about cytotec and his dislike for it. He has seen numerous cases of fetal distress that cannot be controlled because of cytotec and vowed not to use it again after he saw a uterine rupture caused from hyperstimulation in a non-VBAC mama induced with cytotec on his watch.
amniotic fluid embolism is also a risk that we can't forget. Google Tatia French and you can find her sad story. We don't have these types of stories nearly as much with cervadil. If you don't believe it, read this petition where women and families of women tell their stories (read the signatures). Some of these cases that are, right now, in the lawsuit process include:
as well as cases in at least 5 different states (one of which being Texas, where I live).
Again, these cases are not found with cervidil.
But I do see AFE listed as a possible risk of Cervidil too.
https://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm203740.htm
And there are cases of it occurring in conjunction with other induction agents, like Cervidil and Pitocin.
https://ats.ctsnetjournals.org/cgi/content/full/90/5/1694
https://onlinelibrary.wiley.com/doi/10.1111/j.1471-0528.2010.02656.x/full
I don't think anyone here would say that Cytotec carries no risks or that there are no concerns with it. But similar issues exist with other pharmaceutical induction agents. And the fact is, that sometimes induction is medically necessary, risks and all.
I don't disagree with the fact that there are risks with cervadil. In my experience as a doula and mw apprentice, in being around women who have experienced induction, and in counseling women AFTER inductions of many kinds, I see Cytotec risks manifested more often than others. And again, I believe it is because of the reasons I listed (not approved to be broken down into smaller doses and not being able to regulate/stop administration when risks occur).
So, IMHO, the fact remains that there are much better ways for induction with better possible outcomes and better control than cytotec. That is why I think it is more dangerous
I don't think anyone is disputing these things:
1) Unnecessary inductions are bad.
2) If an induction is necessary, Cytotec carries more risks (notably, the you-can't-just-take-it-out issue that's been mentioned in multiple posts, including my original one) and probably should not be the drug of choice.
3) If Cytotec is necessary, the mother and/or the appropriate party (e.g. father) should be informed of the benefits/risks and give consent.
But sometimes induction is necessary, and Cervidil and Pitocin don't work, and what then? C-sections carry an increased risk of PPH and AFE, too...
Mommy to DD1 (June 2007), DS (January 2010), DD2 (July 2012), and The Next One (EDD 3/31/2015)
And I don't dispute that either. I just hope that people understand fully, as was the intent of my post, the risks, from a first-hand account. The risks are real and are more prevalent than with pitocin or cervadil. I normally give women a list of options, including natural and synthetic options, for inducing labor. They even include combinations (i.e. cervadil, then pit, arom then pit, etc..). Cytotec IS one of them.
We talk about, if all else fails and Cytotec and cesarean are your only options left, which would you prefer?
The problem is, often when the rest DON'T work, it is normally because your baby and body are not ready (i.e.: when you are simply past your EDD and there are no risks manifesting) and even Cytotec won't do the job. And, yes, you are right, bottom line - INFORMED choice, not just lots of choices.
I don't think we are in disagreement at all, again, I just wanted to give the POV and story of someone who has lived through the side effects of cytotec.