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  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)