Medication in Pregnancy: Doing Without Knowing

I just finished reading a short article about the use of Odansetron (Zofran), a medication often given to pregnant women to help them when they have nausea and vomiting. While this medication has been WIDELY prescribed for nausea and vomiting in pregnancy it is NOT approved for this purpose. 

Zofran (Odansetron) IS approved by the FDA for the prevention of nausea and vomiting associated with cancer chemotherapy and for the prevention/treatment of nausea and vomiting after surgery.  What this means is using Zofran for pregnant women is an “off label” use.  Off label usage of medication is nothing new and it happens all the time. While I do understand this, I believe that we need to be MUCH more cautious and careful when working with pregnant women.  We need to do better about understanding the risks profile of a medication before putting it widely into practice.  Doing without knowing is NOT okay.

From the article “Although most often used as an antiemetic following chemotherapy, ondansetron frequently is used off-label to treat nausea and vomiting during pregnancy. However, few studies have assessed the safety of ondansetron when used for this indication. A report in the New England Journal of Medicine [1] used Danish national data to determine the impact of ondansetron on risk for spontaneous abortion, stillbirth, major birth defects, and other perinatal outcomes.”

After reading this article, I couldn’t help but think about the horrors of thalidomide.  Sold in the late 50’s/early 60’s, thalidomide was given to pregnant women in off label use for morning sickness. It was untested and after a few YEARS of use and massive birth defects were noted, it was pulled from the market. This was all in the name of stopping nausea and vomiting, which BTW is a NORMAL part of early pregnancy and can even be normal throughout pregnancy if weight gain and fetal growth are appropriate.  But I digress and that’s a topic for another post. My point today… Doing without knowing is NOT okay.

We introduced the electronic fetal monitor (EFM) in the 1960’s in the name of preventing birth defects. The use of the fetal monitor quickly became widely used nation wide without research. It is the number one intervention on labor and delivery units today even though it is common knowledge among birth professionals that EFM has not and does not create better birth outcomes. And in the face of research that shows continuous EFM increases c/sections and intermittent monitoring is safe and effective at detecting fetal distress we continue to use electronic fetal monitors nation wide! In this case we initially did without knowing. Now we know better but since EFM has become such a part of our maternity culture that we still do even though we shouldn’t.

Honestly, this is really is just a little rant. Reading the first part of the article irritated me.  I’m continuously like… SERIUOSLY?!?!  When will we stop experimenting with women and our unborn children.  This article goes on to say that the researchers found no increase in birth defects, miscarriage or still birth. This article highlights however that we still casually do without knowing and this is NOT okay. Doctors and midwives prescribe medications and procedures all the time either without full knowledge of the risks or without full disclosure of the risks. It’s not fair to women and its NOT okay.

The take home message:  Please remember ALL substances that you take, whether it’s a vitamin or hard drugs and everything in between… ALL of them DO in some way, and in some amount, cross the placenta and get to your baby.  Whenever you are prescribed a medication… ask a question. Find out if there is a better/different option. Ask about waiting until later in pregnancy. Ask. Ask. ASK.  Don’t assume everything they give you is necessarily safe, or that it is even necessary.  What medications did you take during pregnancy? Would you take it again?  Share your experiences…

In Birth and Love
Nicole (Dont forget to follow me on twitter @SistaMidwife)

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10 responses to “Medication in Pregnancy: Doing Without Knowing

  1. I appreciate your point about off-label drugs. I was prescribed terbutaline with the goal of stopping preterm labor during my first pregnancy. I was on it for about two weeks until our neonatologist said it was just our care provider’s way of feeling like she was “doing something” but there was no evidence it would reduce the risk of preterm birth. After our daughter was born, research came out about the risks of terbutaline in pregnancy, including neurological impacts. I am very grateful I was only on it for two weeks, but will always wonder if my daughter’s challenges are the result of the drug. You do the best you can with what you’ve got at the time, right? It can be so hard to balance the risks with the potential benefits. She was born at the ripe gestational age of 42 weeks 🙂 But if she had been born at 28 weeks, I might have regretted the decision to end the terbutaline. At the end of the day, I think this is why it is so important to me that women are given good, evidence-based information and support to make the decisions that are right for their families. Thanks for all that you do to keep women informed!

    • Thank you Jeanette for reading and commenting. Yes… we do the best we can with what we know at the time. I remember being in midwifery school and learning it was not dangerous for a woman in labor to walk around even if their bag of water had already broken. I thought it was unsafe and told my patients that as a new labor nurse. That’s what the doctors and my mentors told me and that’s what I told the patients. I’m so happy I know better and I understand that even if something is considered “dangerous” we need to let the mother decide… after we help her get GOOD facts and information… Let her decide what is best and we need to be honest about what we do and dont know. Thank YOU for all you do!

  2. Did you read this part of the article? “The new study of more than 600,000 pregnancies in Denmark found no evidence of major birth-related problems, so women should not be afraid to use Zofran if they need it.” (my source: http://www.huffingtonpost.com/2013/02/27/zofran-pregnancy_n_2776753.html)

    This is my 7th pregnancy, but only my 2nd using Zofran. It has been a godsend. I haven’t lost 15-20 pounds in the first trimester like I usually do, nor have I needed an ER visit for IV fluids. I discussed the risks with my OB and he believes they are minimal. My son (4th baby, 6th pregnancy), my fist “zofran baby,” was born full-term and healthy, and he is my most robust child to date.

    • Hi JoAnna. Thanks for reading and commenting. I actually read a review of the study on a professional medical site not that particular article on Huffington Post. I do/did mention in my post that the article reports no evidence of harm was found. As I pointed out to Diana while Zofran was the focus of the article that prompted my post, it was not the actual point of my post. Regardless of what this ONE study says TODAY, The reality is we have been using the medication for YEARS without knowledge of the risks. This type of doing without knowing is NOT okay. That is the point of this post. I am just saying… we have to do better with getting the information BEFORE we begin to widely use these medications. We have to do better as women, as providers, as doctors, as midwives, as researchers. Read my response to Diana for further points.

  3. Thanks for your clarifications! I appreciate it very much. With my first pregnancy I went through HG completely unmedicated (no insurance), and it was absolute hell on earth. I can’t even think about it without cringing in fear and getting horrible flashbacks. I spent most of it on the bathroom floor praying and crying for relief that never came. It was the most horrible experience in my life. With my last two, the same sickness has returned, but with Zofran (24 mg/day) I have kept functional, and it has been a lifesaver. Being an ardent home-birther, I am (as you say) completely unaware of the situations in hospitals in which Zofran may be handed out unnecessarily – I see more of the reverse, where doctors want to refuse Zofran until the mother is desperately ill in active HG. Both situations are to be deplored.

    And, of course, you’re quite right about medications in pregnancy/labor – there are none without side-effects, and none which do not cross the placenta. It’s definitely a serious issue. With Zofran in true-HG, it’s often a matter of life or death, but in those cases, we can only pray that the baby doesn’t suffer from any side-effects.

    Thanks again!
    Diana

  4. However, with Zofran, it is often a matter of life and death for both baby and mother. With hyperemesis gravidarum, the mother MUST take some sort of medication to keep both her life and her functionality. It’s not something to take lightly, but it’s also a condition that must be treated. Ginger does NOT work. Nor does any other herb or coping method. I am also a no-drugs-during-pregnancy fan, but I am also on high dosages of Zofran during pregnancy for hyperemesis because I (and others like me who suffer from this condition) have no choice. It’s not a matter of trying to escape a minor complaint. It’s a matter of trying to survive and trying to stay out of the hospital. It’s hard to understand hyperemesis if you haven’t been through that hell, but do try to understand that this is not a minor issue or a bunch of irresponsible women unnecessarily endangering their babies’ health.

    Please also know that your statements come across as extremely hurtful to hyperemesis mothers who have been through the nightmare of HG. If you have not been there, you simply cannot know the intense suffering that it occasions. Please do not treat us like that. Saying that nausea/vomiting are normal and that we need to “suck it up” is hurtful to the extreme, and I do hope that you will be more caring in the future. Spending some time on http://www.helpher.org or reading “Beyond Morning Sickness” would help you to get a better perspective on this illness.

    • P.S. I apologize if my comments came across as rude or hurtful – I was very upset after reading your post!

    • Hi Diana! Thank you for reading this post and thank you for your comment. Let me start by saying, my intention is never to be hurtful. I have a shoot from the hip type of style. It’s part of who I am and how I present information, particularly during a rant. If you have personally had people say negative comments to you due to your hyperemesis and those comments have made you feel bad, that is unfortunate. That is unfair to you and I hope that you have done some education with them.

      I am fully aware that Hyperemesis Gravidum is a REAL diagnosis and for these mothers medications may be indicated yet still not always required. I am not sure if you know it but in hospitals across the country Zofran is given out like candy for any mom who comes into the triage area with a complaint of nausea and vomiting. There is a huge difference between using a medication that is indicated and necessary and taken with the risks/benefits discussed and understood. It is an entirely different thing to give medication to a mother who has NO signs of ketonuria, normal weight gain or zero weight loss and normal nausea and vomiting of pregnancy. This happens a LOT. Many women get Zofran without any other option ever being discussed and often when they don’t need it.

      I never said anything about “suck it up.” What I did say and I stand behind my statement: “This was all in the name of stopping nausea and vomiting, which BTW is a NORMAL part of early pregnancy and can even be normal throughout pregnancy if weight gain and fetal growth are appropriate.” Notice I said normal in EARLY pregnancy and CAN be normal IF… You are speaking of a situation where a mother has a legitimate medical issue/indication for the medication. It’s like when I rant about the high rates of c/sections. This does not mean I think ALL c/sections are bad. I am highlighting the fact that we have way too many of them. And in this post I am highlighting the fact that we do/give/prescribe too much during pregnancy without an understanding of the ramifications of those decisions.

      Thanks for to the website which actually supports my point… From the site “HG is a debilitating and potentially life-threatening pregnancy disease marked by rapid weight loss, malnutrition, and dehydration due to unrelenting nausea and/or vomiting with potential adverse consequences for the mom-to-be and the newborn(s).” Again these are NOT the women I am speaking about. And the vast majority of women who I have seen given Zofran do not fall into this category. Zofran was actually not even the point of my post. Rather the point is… My take home message…. ALL substances taken during pregnancy DO in some amount, cross the placenta and get to your baby. Ask. Ask. ASK. And don’t assume…

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