Monday, May 21, 2012

Misoprostol (Cytotec)





I can't figure out how to reposition the video of uterine rupture but if you are going to be reading about cytotec it's important that you understand the concept of uterine rupture and the severity of it. It is a horrific event that is life threatening to the mother and baby. It has a high incidence of fetal and maternal morbidity. :( baby can die from lack of oxygen and momma can die from hemorrhage. Take the 3 minutes and watch the video so when uterine rupture is referenced you understand what it is.

I am doing a whole lot of ongoing research into what Cytotec is. But for those out there who are just unaware of what this drug is I encourage you to educate yourselves so you can make a well informed decision that's right for you.

To give you some background here Misoprostol is used to prevent ulcers. Some physicians and midwives use (despite the manufactures warning) it to induce labor.

Why the controversy?



1) Let's start with the basics shall we? Here is a warning that's in the drug information:

WARNINGS
CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN CYTOTEC (misoprostol) WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY
http://www.rxlist.com/cytotec-drug.htm

Photo of medication

2) It has not been approved by the FDA for this use. In fact the actual manufacture of this drug has released a statement in great detail about why this drug should not be used for the induction of labor. Please, please, please, if you read nothing else about the drug, read this (I provided the link and posted the full text below):

 http://www.aims.org.uk/Journal/Vol13No3/searle.htm


Full Text of Searle's Warning

Searle
5200 Old Orchard Road
Smokie, Illinois 60077
IMPORTANT DRUG WARNING CONCERNING UNAPPROVED USE OF INTRAVAGINAL OR ORAL MISOPROSTOL IN PREGNANT WOMEN FOR INDUCTION OR LABOR OR ABORTION
August 23, 2000
Re: Cytotec (misoprostol)
Dear Health Care Practitioner:
The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion.
Cytotec is indicated for the prevention of NSAID (nonsteroidal anti- inflammatory drugs, including aspirin) - induced gastric ulcers in patients at high risk of complications from gastric ulcer, eg the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.
The uterotonic effect of cytotec is an inherent property of prostaglandin E1 (PGE1), of which Cytotec is a stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy.
Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy, amniotic fluid embolism, severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.
Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses. Therefore, Searle is unable to provide risk information for Cytotec when it is used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotecon the later growth, development and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established.
Searle promotes the use of Cytotec only for its approved indication. Please read the enclosed updated complete Prescribing Information for Cytotec.
Further information may be obtained by calling 1-800-323-4204.
Michael Cullen MD
Medical Director, US
Searle

Additionally, the chair person of the Association for Improvements in the Maternity Services dictated this:

HEALTH WARNING

The use of Misoprostol (Cytotec) has crept into British maternity units as this drug is a cheap and attractive (to the clinicians!) method of inducing labour. It can produce horrendous contractions and has resulted in hyperstimulated uterii, maternal and infant death and uterine rupture. It is not licensed in the UK for induction of labour.
The problems with this drug have provoked Searle to issue the following warning, which it sent to all health care practitioners in the United States of America. As the British have not, I presume, made a fuss about this drug, no similar warning has been issued in the UK, to our knowledge. (Drug companies rarely issue health warnings, or specific information about their drugs, unless required to do so by Government regulation or public pressure).
Any woman who is told that she is to have her labour induced should ask for the name of the drug to be used. Any midwife or health practitioner intending to use this drug should give the mother a copy of the Searle warning first. She can then give informed consent to the use of this drug.
AIMS has written to Searle asking for a copy of the package insert and we would be most interested to receive a copy from any source.
The full health warning from Searle is reproduced on this site.
Beverley A Lawrence Beech
Hon Chair, AIMS

* Some people would argue that there are lots of drugs that have unlabeled use for which they are routinely used for. I understand why too. If the drug can be used for something else but doesn't have to go through all the hoops of the FDA again, it saves people money. The FDA reviewing a drug is a lengthy and costly process. However I would ask if all those drugs have the medical director of the manufacturing company personally write letters asking that they not be used for those uses like they did for Cytotec? I would think not. As mentioned it saves everyone money and time if unlabeled uses are utilized because they can bypass the bureaucratic mess that is the FDA. Surely the medical director would be interested in what is best for his company from a financial standpoint and what would be best for his company from a financial standpoint would be to ignore the whole thing. Unless this man has ethical or litigious dilemmas that he must address.

* Some other people may also argue that ACOG wrote a rebuttal to the FDA in response Searle's letter saying that not enough research has been done warranting that Cytotec be banned as a medication for labor induction. That statement works in synergy to support Searle's letter that Cytotec indeed needs more research before it could ever be used for induction and cervical ripening usage. Just because "there is not enough research" on a compound is not a good reason to use it. I'm pretty sure medical professionals tell people who use natural remedies the same thing every day in their office.

3)"After Cytotec is inserted in the vagina, it dissolves instantly. There is no turning back. 

There is nothing that can be given to reduce the severe tetanic (very violent and painful) contractions wearing on the mother's uterus and depriving the baby of oxygen far longer than can be tolerated. These and many other side effects do not need to continue to occur. Alternative interventions are available to induce labor and can be turned down or off (Pitocin) or withdrawn (Cervidil, Prepidil)."
That's straight from The Journal of Perinatal Education, the article The Freedom to Birth—The Use of Cytotec to Induce Labor: A Non-Evidence-Based Intervention. I highly encourage you to read the whole article. 
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2684033/

4) Abortions is one of its labeled indications for use. Yeah, Seriously.


What to do with this info? 


1) Ask your care provider about it before you are ever in labor so you have time to think about it- and ask them to provide the peer reviewed research supporting what they say. Don't assume that you will never be in a situation where this is the suggested medication for you. Some facilities exclusively use this drug for labor induction & cervical ripening.


2) If offered this drug ask why specifically this drug? Sometimes the only answer is because it's cheap. It should be your decision if you want to pay more for lowering your risk of maternal and fetal death, not theirs. If they don't have a great answer ask if there are alternatives.


3) ask how much you are getting and by what route? It sounds silly you have to ask this but in all the commotion of labor you would be surprised what is neglected to be told to you. And how quick something can be shoved into you without your oral consent. The following link provides some good info on Cytotec. While I am not recommending or endorsing anything here (obviously you should talk to your doctor about it,) it helps you understand how getting a higher dose is a serious risk and how certain routes are more risky than others. It also has some good comparisons with other drugs.
http://www.misoprostol.org/File/GuideIOL.php

4) Educate yourself and be prepared in advance!!!There is so much information handed to you on interventions during L&D it is very hard to take in all at once, especially if you are in labor. The best way to have a high satisfaction in regards to your birth is to know that you were as educated as much as you could be and you made the decision that is best for you and your family. It's important to know what questions to ask because only you know what value you place on certain things. If you don't educate yourself how will you know what to ask? Plus you don't want the anxiety of decision making to damper your birthday. The best way to stay cool, calm, and collective is to know what is going on.

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