A Cytotec Induction...Effective and Safe?

In the United States, a Cytotec induction has become part of mainstream obstetric practice.

Cytotec - misoprostol - was never approved by the FDA for labor induction. As a matter of fact it was never approved for pregnant women at all...so why is it used on pregnant women? It is done because all doctors know that there is a huge loophole in the drug approval system.

Indeed, once a drug is approved by the FDA for a specific medical condition and once it is put on the market, there is absolutely nothing to prevent any doctor from using that very drug for any indication, in any dose, for any patient he or she chooses.

You may want to reread that last paragraph. Actually, we will write it again just for you, please read it slowly and please let this information seep in:

This process is called "off-label" use and most drugs in the US - about 90% in fact - are used off-label.

Cytotec Induction: What Do Doctors Have to Say?

So what to doctors have to say about that? Why do they use Cytotec when clearly the drug was not approved for labor?

The answer is simple: it is done all the time.

And that would be the truth...remember 90% off- label use?

It used to be that misoprostol was even contraindicated - advised against - in pregnancy by the manufacturer. But this labeling was changed to be contraindicated only until labor because it is well known misoprostol will bring on labor - hence it use for abortions.

If - however - that was not bad enough it is not the only reason to be concerned about Cytotec inductions.

Not all risks are created equal. The fact that most drugs are used off-label does not mean that all off-label use is safe.

Here is an analogy: the fact that over 60% of Americans are overweight does not mean that the remaining 40% should follow suit just because, "heck, everyone else is!"

Cytotec Induction: What Does The FDA Have to Say?

Do you know that a survey - done by the FDA - of 731 pregnant women revealed they had been given 10 drugs while pregnant!!! Of the 10 drugs all were given off-label, nine of them carried relatively little risk while the use of the tenth drug - the prostaglandins including Cytotec - have proven serious risks including uterine rupture...following which one in four babies die.

We don't know about you but it is scary to think that doctors are taking matters into their own hands when it comes to deciding on the use of medications. They are doctors, not pharmacists.

Who are they to determine whether a drug is safe or unsafe?

Moreover, it puts the life of women and their babies at great risks. And what ever happened to "first do no harm?"

The doctors - and believe it or not some midwives - who use Cytotec don't seem to understand the chances that they are taking with the life of others.

Using any drug without any scientific evidence or trials means we have unwillingly become the guinea pigs for a slew of drugs.

Moreover, here is a list of organizations who do and do not recommend a Cytotec induction:

The FDA's Position

The most recent warning from the FDA, issued May 2005 read as follows:

FDA ALERT: Risks of Use in Labor and Delivery

This Patient Information Sheet is for pregnant women who may receive misoprostol to soften their cervix or induce contractions to begin labor. Misoprostol is sometimes used to decrease blood loss after delivery of a baby. These uses are not approved by the FDA. No company has sent the FDA scientific proof that misoprostol is safe and effective for these uses.

There can be rare but serious side effects, including a torn uterus (womb), when misoprostol is used for labor and delivery. A torn uterus may result in severe bleeding, having the uterus removed (hysterectomy), and death of the mother or baby. These side effects are more likely in women who have had previous uterine surgery, a previous Cesarean delivery (C-section), or several previous births.

Despite of these warnings, the manufacturers of misoprostol and ACOG are pushing for its approval.

Cytotec Induction: ACOG's Position

We know what you are thinking: "How can ACOG possibly be willing to stand alone in this position against the best scientific opinions of the world?"

The short answer is because it is good business.

It is a fact that many OBGYNs - and members of ACOG - already use Cytotec induction. Why? Well, simply for its convenience.

On a side note, if you thought that ACOG was there to support you - the patient - think again. ACOG exists to support its members - yep, OBGYNs - and the way they practice medicine.

If you thought ACOG was a "prominent medical organization," you would be misguided. It is a union designed to protect its members not the public - meaning you.

However, it is customary for ACOG to try to find support for its - dare we say odd and dangerous - positions. ACOG likes to find a scientific paper promoting its views.

It hit the jackpot with an article published in the New England Journal of Medicine written primarily by A.B. Goldberg as well as other authors.

The authors of this paper do a superb job at twisting data until the said data says what they want it so say. For example:

If this is true - and it is - you should be alarmed by this practice.

However, the justification that something is "common practice" should not be a justification for a bad - and in this case harmful - practice.

The common usage of anything does not prove - under any circumstances - that it is a good idea nor does it prove its safety.

Next the authors of the article go on to say:

Really?

Off-label use means that there is no sound scientific evidence.

No one can deny the fact that Cytotec was used without any sound scientific evidence.

Instead, the sound scientific evidence is gathered by using the drug on unsuspecting patients. And we know for a fact that with the off-label use of misoprostol for Cytotec induction there are many problems.

The Use of Cytotec Induction

At the beginning of its use - in the early 90s, no one even knew what the proper dose should be and everyone was in fact experimenting with dosage and protocol on unsuspecting women and their unborn babies.

What this means is that thousands - hundreds of thousands? - of women were submitted to off-label Cytotec inductions without proper warning and therefore proper informed consent.

To put it simply, women - and their babies - were used as guinea pigs when no one knew what the consequences might be...yes, it is kind of like playing Russian roulette and we seriously doubt you - or anyone else - would willingly volunteer for that game.

However, by the end of the 90s, evidence was starting to trickle in - by then Cytotec induction had been used for almost 10 years! That is also alarming - 10 years and how many lives?

The evidence was that a Cytotec induction especially for a VBAC - vaginal birth after c-section - could be deadly as hundreds of women's uterus ruptured putting their life and their baby's life at risk. We know from very reliable sources that some have also started to link the use of misoprostol with fluid embolism deaths.

How many babies died? We don't have exact numbers.

How many mothers died? Too many.

Yes, lives were lost because of such an experiment of off-label drug use with Cytotec induction.

As a side note, most - if not all - of the drugs used on pregnant women are used off-label...

Cytotec Induction: Is ACOG Rethinking Its View?

So you would think that by now - since almost 20 years has gone by - ACOG is now rethinking its view...right?

Sorry, you would be wrong.

ACOG actually is pushing for an

increase

By the way, you may by now be wondering what does "sound scientific evidence" really mean?

No one knows...yes, no one knows as there is no agreement on this subject.

Moreover, ACOG also never comes out to - plainly - say a Cytotec induction is "safe."

ACOG also never comes out to - plainly - say a Cytotec induction is "unsafe."

What ACOG does do however is muddle the playing field with faulty data...let us explain:

Indeed, the authors of the (one) article - on which ACOG bases its views - lump together all Cytotec uses. What does this mean?

First trimester abortions, Cytotec inductions, postpartum use are all lumped together which should not be done. Moreover the claim by the authors that "Two hundred studies involving a total of more than 16,000 women" is misleading if not an all out lie.

The truth is that the number of studies on Cytotec induction are far fewer and that most of them are not randomized experimental trials. Moreover, all of them use too small of a sample to have any statistical power.

Another part of this paper describes the efficacy of Cytotec induction which was never questioned in the first place. Yes, it works!

The risks however are never addressed. They do address that there are a "few" adverse effects:

Death - both maternal and/or the baby - is put on the "rare adverse outcomes."

The authors do admit that the true risks and frequency of these "rare adverse effects" remains unknown. So basically...we don't know enough...but we'll keep on using this drug on unsuspecting women anyway.

This article also mentions that there is no consensus on the correct dosage...a pretty important point don't you think?

So we ask you: is this paper sound scientific evidence?

Cytotec Induction: What Is The Actual Risk of Rupture?

No one can deny the fact that - if Cytotec is used - there is a huge increase in the risk of uterine rupture during a VBAC as well as during a normal delivery. Let's look at some numbers:

But instead of stopping the use of Cytotec for inducing labor, ACOG instead condemned the use of VBACs!!! Once again mothers and babies pay the price.

Note: As of the Spring of 2010, ACOG has reviewed and changed its recommendations on VBACs.

Why does ACOG then persist on using Cytotec induction when the benefits to the mother and baby certainly do not justify its use?

The only reasons we can think of are that it works and it is already being used. We won't mention the pharmaceutical industry which is the biggest pig at the trough so to speak and which benefits highly of "off-label" uses of medications - or in the case of Cytotec induction..."contraindicated use."

Obviously it does not matter to ACOG that a large amount of prominent organizations are against the use of Cytotec inductions.

Don't you think that with Cytotec induction and the consensus on its use still unclear that doctors in this case should stick to the oath that they took which states:

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Sources:
1. Rayburn, W. and Farmer, K. (1997). Off-Label Prescribing during Pregnancy. Obstetrics and Gynecology Clinics of North America 24 (3): 471-8.
2. Goldberg, A.B., Greenberg, M.B. and Darney, P.D. (2001). Drug Therapy: Misoprostol and Pregnancy. NEJM 344 (1): 38-47.
3. Lydon-Rochelle, M., Holt, V., Easterling, T. and Martin, D. (2001). Risk of Uterine Rupture during Labor among Women with a Prior Cesarean Delivery. NEJM 345 (1): 3-8.
4. Dr. Marsden Wagner article
5. Midwifery Today
6. www.cytoteccase.com/Doctors%20v%20FDA.htm
7. http://www.drugs.com/mmx/cytotec.html