Pregnant women should take acid inhibitors with caution
November 24th, 2010
05:03 PM ET

Pregnant women should take acid inhibitors with caution

Pregnant women who take acid-suppressing medications called proton-pump inhibitors  are not at an increased risk of having babies with birth defects, according to a study published in the New England Journal of Medicine. However, an epidemiologist from Boston University School of Medicine, in an accompanying editorial, calls the results "reassuring" but "far from definitive."

"There's no evidence that they do any harm, but we don't yet have as much safety evidence as we would like," said Boston University's Dr. Allen Mitchell. "Unlike experimental studies, a single observational study can't provide definitive results."

Previous smaller studies, including one published in the American Journal of Gastroenterology in 2009, suggested that these drugs can be used safely while a woman is pregnant.

This NEJM study is the largest to date and included more than 840,000 live births in Denmark between 1996 and 2008. The exposure to the proton pump inhibitors ranged from four weeks before conception to the end of the first trimester of pregnancy. The study also included other information such as the history of birth defects in siblings, the mother's use of certain other classes of drugs, smoking status and age at conception. The researchers did not study the reasons why the women were on the medications, nor the use of folic acid, which is widely recognized as playing a role in preventing birth defects.

Proton pump inhibitors are available by prescription and over-the-counter and are taken for symptoms of gastroesophageal reflux or heartburn. The American College of Gastroenterology says symptoms, including discomfort behind the breast bone, a "sour" stomach or pain in the upper abdomen or chest, often are resolved in pregnant women after they give birth.

In the study, of the women who took proton pump inhibitors, 3.4 percent had infants who had major birth defects; in the women who didn't take the drugs, 2.6 percent of infants did.

Mitchell agrees with the study authors that these data provide only a broad and incomplete overview of the most common proton pump inhibitors (omeprazole, lansoprazole and esomeprazole, sold as Prilosec, Prevacid and Nexium, respectively.)

"We know that specific medications in the same group can have different risks for birth defects, so we need more data about specific drugs in relation to specific birth defects," he said, in order to be sufficiently confident about the safety of the drug.

Mitchell pointed to two examples in particular.  According to the March of Dimes, pregnant women taking the drug thalidomide in Europe, Canada and other places in the 1950s and 1960s often gave birth to children with missing or shortened limbs. In addition, the drug Accutane has been linked with brain and heart defects.

He stresses that the proton pump inhibitors do not have devastating effects on the fetus as these drugs did, but said that if a pregnant woman believes she needs a proton pump inhibitor, she should talk to her physician first.

“A woman with a chronic gastrointestinal condition who is already on PPIs and who plans to get pregnant should discuss with her doctor any potential risks associated with both her condition and with her medication. Those without chronic conditions and who get pregnancy-associated gastroesophageal reflux, and who are about to take PPI, can take them with confidence that these drugs are not associated with increased risk of birth defects on aggregate,” said study author Dr. Bjorn Pasternak.

The researchers found an unexpected, slight increase in the risk of developing birth defects in women taking proton pump inhibitors other than omeprazole in the period right before conception. But Mitchell says additional studies are needed to study this observation further.

"It may be prudent to consider omeprazole to be the  PPI of choice when PPI treatment is clearly needed for women of childbearing potential and particularly for those who are planning to become pregnant," he wrote in the editorial.

soundoff (47 Responses)
  1. HGSurvivorx2

    I can attest that while suffering from severe Hyperemesis Gravidarum, I was OB approved, to take 450mg of Zantac per day (among other life-saving medicine). It barely made a dent in the acid reflux. Three years post partum and that reflux *still* haunts me and I'm still on meds.

    My daughter was born healthy, with no birth defects despite the problems during the pregnancy. Check out http://www.helpher.org and you'll see for yourself that there are hundreds of other women who also took PPIs and their babies were born healthy.

    November 24, 2010 at 17:44 | Report abuse | Reply
  2. Margo

    I took Prilosec in the 2nd and 3rd trimesters, and my son is just dandy. However, I didn't need them in the 1st trimester, so I don't know how they would affect developement then.

    November 24, 2010 at 18:14 | Report abuse | Reply
  3. Jennifer

    That's good news because I take nexium daily to help with my acid reflux and I'm 4 months pregnant. I've been on it for over 2 years now.

    November 24, 2010 at 18:33 | Report abuse | Reply
  4. Christin

    If you do enough studies, you will always find something bad.

    November 24, 2010 at 18:39 | Report abuse | Reply
  5. Mom of 5

    I took them with ALL pregnancies (4) and all of my children were born healthy

    November 24, 2010 at 18:43 | Report abuse | Reply
  6. Mom of 2

    I took them before, during, and after both of my pregnancies and both boys were born healthy. I am a pharmacist and researched the smaller studies prior to taking Nexium during pregnancy. I didn't see any problems with it then and am reassured by what I am reading now.

    November 24, 2010 at 19:09 | Report abuse | Reply
  7. Dr wachsman

    As a physician, my advice to pregnant patients – i.e., if you have reflux and the Tums aren't helping, take famotidine (Pepcid)20 mg daily up to twice daily – will not change as a result of this study. There still is some risk associated with the PPI drug class and as such they should still be avoided if there is a reasonable, cheap and over-the-counter alternative. In other news, it's still bad to smoke cigarettes during pregnancy.

    November 24, 2010 at 19:42 | Report abuse | Reply
  8. MOM of 4 and one on the way

    During my 3rd pregnancy, pepcid did the trick. However, my 4th pregnancy, pepcid didn't help at all. I have since been diagnosed with a hiatal hernina. My 4th child was born healthy after taking omperazole the whole pregnancy. I am pregnant with my 5th child and taking omperazole daily as well.

    November 24, 2010 at 20:30 | Report abuse | Reply
    • Meagon

      I’m also taking Pantoprazole for my acid reflux and have a hital hernia.
      I’m concerned! Should I stop this medication?
      I’m currently 8 weeks pregnant

      April 1, 2019 at 13:33 | Report abuse |
  9. benniebory

    Brilliant articles the information you have share is brilliant and really helpful towards the pregnant woman.I definitely this information wife you recently become pregnant..

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    November 25, 2010 at 13:06 | Report abuse | Reply
  10. Dr.Dubrawsky

    As a professional,and a citizen of this big country of the U.S.A.,I learned that:"When there smoke,there is fire"
    There must be a reason why suddenly,people are talking about intake of P.P.I. in pegnancy.
    Personaly,I would not label:"Safe" any medication in pregnancy,that has side effects(Side effects means:Something is wrong).
    Pregnancy is the most precious time in life of a woman:She is building a new creature as copy of her and her man.
    Let us not spoil it.
    As for what to do about:Hyperemesis Gravidarum?My answer is:Oat Bran,Soy Millk and Niacin.Will it work?Of course it will.
    You will sleep like baby.How do I know?Trust me,I tried it over the last 3 years.I have a pretty large Hiatal Hernia.In the passing years,I forgot about it(So did my patients). Finaly remember:I am a man,not a woman,So pregnancy for me is:"Out of question"
    For how what and when to take this food and vitamin.I am availablle to detail.

    November 25, 2010 at 15:12 | Report abuse | Reply
  11. choicechemist

    I had recently written on how medicines like Nexium that are used to treat heartburn can be especially dangerous the pregnancy phase – http://www.choicechemist.com/should-pregnant-or-breastfeeding-women-consume-nexium

    You may want to thread these medications with caution because it may have undesired effects and you wouldn't want to harm the unborn child.

    May 29, 2013 at 05:25 | Report abuse | Reply
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  13. Dr. Julie

    From the Conclusions of the NEJM study:
    "In this large cohort, exposure to PPIs during the first trimester of pregnancy was not associated with a significantly increased risk of major birth defects."
    I understand caution, but please start with the data when explaining results to a lay audience. In a large study, there was no difference in the prevalence of birth defects between those who took PPI's and those who did not. That's what the study demonstrated, it is what it is. We can interpret as we like, but let's not ignore the data and compare PPI's to thalidomide.

    August 25, 2014 at 16:25 | Report abuse | Reply
  14. fernando

    I took pantoprazole and zantac for almost 3 to 4 months and stopped taking them 3 or 4 weeks before i conceived. I did not know i was pregnant until like 4 weeks and during like the 3rd week i took 2 tablets each of Pantoprazole and Zantac just once when i had acid reflux. I'm very concerned about this. Please let me know if this is fine. Also i haven't taken any medications after i got to know i was pregnant. Thanks

    October 5, 2016 at 17:08 | Report abuse | Reply
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