The Great Cytotec Debate

Fear of a name increases fear of a thing itself.” Albus Dumbledore

Of course, the name in the quote above references is Voldemort. You know, the bad guy in the Harry Potter series. In the birthing world, our Voldemort of the moment seems to be Cytotec aka Misoprostil aka Miso.

The similarities between Voldemort and Cytotec end at the fear of the mere mention of the name itself. There’s also the fact that they’ve both been the catalyst in the deaths of people. Either real or imagined.

It’s no great mystery that there is still a lot of fear surrounding the use of Cytotec in the birth community today.

However, as a doula and doula trainer, I’m often puzzled by assertions and claims made by birth professionals when it comes to this issue. There is a lot of outdated information. Then there’s the complete lack of understanding as to the use of this drug. There’s also confusion about the use of drugs in an off-label context.

Let’s start by looking to the past.

When Misoprostol first appeared in obstetrics for the induction of labor, there was no established “safe dose.” There were no randomized controlled trials to establish safety and efficacy. Essentially providers across the US were left to try and figure out what worked best. As a result, the doses given were too high, and tragedy occurred. We’ve also learned that the use of prostaglandins in women with a previous cesarean scar is a huge no-no.

Cytotec was being given to women with a history of cesarean surgery add in the lack of any established ‘safe dose’ and disaster ensued.

Today we have over 11 clinical trials on its safety and efficacy. Firm guidelines were developed and safe doses established. In my community, most providers have moved away from using scored tablets and use an oral slurry. Even the World Health Organizations includes misoprostol in its recommendations for induction of labor.

Then we have the “off-label” discussion.

Off-label use of drugs is an accepted practice in the medical community. Children who are born with congenital heart defects that require surgery can be given Viagra off-label to help support their hearts.

Bet you didn’t know that Magnesium Sulfate, when used for premature labor and preeclampsia, is being used off-label.

Off-label use in and of itself is NOT wrong. But all too often I see “Cytotec is not approved for labor induction, it’s being used OFF LABEL” as justification as to why it shouldn’t be used at all. If that’s the case, then Mag Sulfate is off the table now too, right?

Let’s talk about the black box warning.

The current warning against use in pregnancy states:
WARNINGS. Cytotec should not be taken by pregnant women to reduce the risk of
ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs).

The warning against Cytotec is specifically for its use to treat ulcers during pregnancy. Not for induction of labor.

What about those side effects listed in the package insert?

All package inserts list possible known side effects. Have you read the package inserts for Mag Sulfate, Pitocin, etc.? Same types of disclosures.

In addition to the more recent updates to the package inserts to outline the risks for the  accepted use of Cytotec in obstetrics, randomized controlled trials have been conducted to test and establish efficacy for a Misoprostol Vaginal Insert that will be used for cervical ripening and labor induction.

Having said all of the above, you might wonder where I stand when it comes to Cytotec and its use in obstetrics.

My general approach is to avoid the use of “always” and “never” much preferring the middle ground of “It depends.” I’ve had clients participate in the MVI trial I linked above since one of our local hospitals was the study site. My clients have seen Cytotec inductions be effective if not intense. They’ve also been effective and totally bearable without pain medication. I’ve seen the same with the MVI. In my 20 years of experience, I can’t say that there is one clear “winner.” It’s not a clear cut case of one being better than the other.

My bottom line is that any drug can be abused and misused.

In my approach to discussing induction methods with clients, I suggest they do their own research. Why are we inducing? Is there a medical reason? What is her Bishop’s Score? What is her personal risk threshold when it comes to the use of induction agents and cesarean?

When talking specifically about Cytotec we discuss it’s history, how it came to be used, why it is considered preferential to some providers, how it’s administered and the possible variances in doses when using a scored tablet, and what viable alternative induction methods are available and their benefits or risks.

Beyond that, it’s up to my clients to decide what they feel is the best option for them.

I have no desire to sway them in any particular direction. At the end of the day, my risk threshold may be different than theirs. In the end, I am not the one who will have to live with the outcome of this decision. My personal opinion has no place in the discussion.

At the end of the day, we as birthing professionals need to be able to sit down and intelligently discuss the use of Cytotec in obstetrics.

We benefit no one, least of all our clients when we run around like our hair is on fire at the mere mention of the possibility of its use.

Using arguments like “Have you read the package insert?” or “It’s not been approved for use in labor.”  or “It has a black box warning for pregnancy use.” to argue against its use just make us look silly and unprofessional.