Gross Oversight: Cytotec not on FDA’s warning list

The FDA released a list of drugs that they consider to have the potential for serious risks or drugs that have new safety information identified by adverse events. Since when is a cytotec (misoprostol) rupture not serious enough in terms of risk or adverse event to warrant being placed on a FDA-issued alert?

GROSS OVERSIGHT . . . or perhaps it’s safe to say that this information is being suppressed by the medical machine?

For those of you who may not know, Cytotec is an ulcer medication that is misused to induce labor. Women know to ask for it; doctors know to prescribe it – it’s so easy. However, it can cause overstimulation of the uterus leading to emergent cesarean delivery, uterine rupture, hysterectomy, and even death (of baby and/or mother). It is absolutely NOT appropriate to use this drug on a pregnant or laboring woman.

Here are a couple of links for your to peruse:

I am not seeing this on a previous AERS list. If it is there, please do let me know via comments. Regardless, it should remain on this list until its use on pregnant women ceases.

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9 responses to “Gross Oversight: Cytotec not on FDA’s warning list

  1. You are totally correct… Cytotec should be listed on this new FDA list. The reason it is not is b/c they are only, unforturnately by law, allowed to warn of the adverse events of drugs that ARE APPROVED for specific things. OFF LABEL use ( which is what cytotec is when used to induce labor) does not come under the jurisdiction of the FDA, or any agency at present, which is a GROSS miscalucation for the public, and needs to be changed. …The Tatia Oden French Memorial Foundation has been dealing with this very issue with the FDA for 4 years now. LEGISLATION passed by the US Congress is the only thing that will change this.
    If you want to help create this legislation please email me.
    Maddy Oden

  2. Maddy,
    First let me say that I am honored you took the time to read and comment on my weblog. I am well aware of the work you have been doing and your personal stake in this issue. THANK YOU for all you are doing to bring about awareness and keep this nasty drug away from pregnant women and their care providers. (I should also point out that Maddy Oden was name the “Conscious Woman of the Month” by Conscious Woman, an outstanding advocacy/education group.)

    Please feel free to direct me (and my readers) to any information we should know about that would help us get state and national legislation moving forward on this issue. I saw a petition (from 2004?) – maybe it’s time to start up a new one??

    ~ Kimberly (labortrials)

  3. Kimberly, I followed you back here from my blog. It’s great that you’re drawing attention to this – appalling that you need to in the first place!

    *No one* should be using Cytotec to induce labor. Period. This is a no-brainer.

  4. Oh, I forgot that WordPress has me listed as Kittywampus – that’s the name of my blog. My nom de blog is Sungold. Sorry for the confusion.

  5. Let me say straight up I am NOT a proponent of Cytotec. I have many reasons for it. But I do think there is a place for it occassionally. I would hate to see it banned outright. However, I think it gets used way way too often without much thought. I can’t remember the last time I used it. It has been a long time. The biggest reason I hesitate…I have seen a pt with no previous uterine surgery have a ruptured uterus. Although this risk could potentially be seen with any medication used for induction, Cytotec can’t be taken out or turned off. It is what it is. And the other reason…I worked at a place many years ago where they were using it PO rather then intravaginally. Approximately 20-30 mins after taking it by mouth there was almost always a large FHR deceleration that was approximately 3-5 mins and then it would return to baseline. Although I have not seen that happen with intravaginal use, it makes me very very skittish that we do not know what is going on with that baby. Might I add the box clearly says it is a Category X as well. Interesting topic, thanks.

  6. Sungold, thanks for visiting! It’s tough for us wordpressers who used one name to create a profile and then added blogs later. There’s no way for me to post as “labortrials.” Ack!!

    Sharon, thanks for your thoughts on this. I wasn’t aware that FHR decels accompany cytotec inductions. I suppose if one by-product is uterine contrax that it makes sense the baby’s HR would respond accordingly. Obviously more research is needed if anecdotal evidence suggests FHRs following cytotec induction.
    I am curious to hear what your reasons for using cytotec might be!

    ~ Kimberly

  7. Kimberly, I have a friend who is an L&D nurse in NYC & the hospital she works at banned cytotec 8 years ago. If you remember when I went in for my first induction, they were going to give me a dose of misoprostal after they did some fetal monitoring. I was LUCKY that I was already in labor & therefore unable to take the drug. I had no idea at the time what the drug was or what the accompanying risks were. It’s one of those moments where I thank my lucky stars I skated out of that one. I’ve been vigilant in warning expectant mom’s I know to avoid miso/cytotec at any and all costs.

    and p.s. I miss you! Call me! How are you?

  8. Jeannine, I am so thankful that there are mainstream birth moms like yourself who are warning pregnant women about miso/cyto.

    I miss you too and will call over the weekend… that’s the next opportunity to breathe…

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