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Is It Safe To Take Omeprazole In Pregnancy?

Is It Safe To Take Omeprazole In Pregnancy

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IN THIS ARTICLE

Omeprazole is a medication grouped under the class of drugs named proton pump inhibitor (PPI) and is indicated for the treatment of heartburn and other symptoms related to gastroesophageal reflux disorder (GERD) in adults and children. It is also used for duodenal ulcers in combination with clarithromycin and amoxicillin in patients with Helicobacter pylori infection. Other conditions include gastric, erosive esophagitis, and disorders of stomach acid hypersecretion such as Zollinger Ellison syndrome and multiple endocrine tumors (1).

This post discusses the use of omeprazole during pregnancy and whether it is safe for pregnant women and the growing fetus.

Why Is Omeprazole Prescribed During Pregnancy?

Heartburn is a common problem affecting about 30-50% of pregnant women. The condition causes discomfort and increases the incidences of nausea and vomiting (2). The hormone progesterone increases during pregnancy and causes muscles between your stomach and esophagus to relax, resulting in acid reflux.

Additionally, the growing baby presses on the stomach, making heartburn common during late pregnancy (after 27 weeks). Medications are required to relieve the symptoms when dietary or lifestyle changes are not effective enough. Omeprazole is one such medication prescribed during pregnancy as it decreases the amount of acid produced by the stomach (3)(4).

Is Omeprazole Safe In Pregnancy?

Omeprazole is usually considered safe for use during pregnancy but should be taken in consultation with your doctor to avoid any adverse effects (3)(5). The US Food and Drug Administration (FDA) initially listed omeprazole as a Pregnancy Category C drug(showed risk in animal studies but data from human studies are inconclusive).

Studies in animals and multiple cohort studies in pregnant women did not show an increase in the risk of adverse outcomes during pregnancy. However, as sufficient well-controlled studies are not available on the use of omeprazole in pregnant women, the FDA presently recommends that the drug should be used only if clearly needed during pregnancy. Thus, the medicine should be limited to cases where the benefits outweigh any risk (1).

Are There Any Pregnancy Complications Associated With Omeprazole Use?

A recent analysis of data from FDA adverse event reporting system (FAERS) has shown a relationship between omeprazole use and the risk of cholestasis in pregnant women. Intrahepatic cholestasis of pregnancy (ICP) is a common liver disorder where bile flow from the liver is obstructed. Typical symptoms include intense itching, dark urine, and abnormal liver function tests. However, extensive research is required to conclude any definite connection between omeprazole and ICP. Women with existing or chronic liver problems should be extra cautious before taking omeprazole.

Does Omeprazole Cause Birth Defects?

Every pregnancy has a certain baseline risk of birth defects, and a drug is judged based on whether it increases this risk percentage. Multiple studies demonstrate the safety of omeprazole during pregnancy. A study on 113 pregnant women exposed to omeprazole did not show any increased risk of birth defects (6).

A large study from Denmark (840,000 births) could not establish any significant link between PPI usage in the first trimester of pregnancy and birth defects (7)(8). When tested in rats and rabbits, omeprazole at doses corresponding to 5.6 to 56 times higher than in humans showed loss of fetus and pregnancy complications (9). These findings may indicate that the prescribed dosages of omeprazole are unlikely to cause any adverse effects.

Does Taking Omeprazole In Pregnancy Cause A Miscarriage?

Studies reveal no additional risk of spontaneous abortion (miscarriage) with omeprazole use. A meta-analysis of published studies using data of 1530 pregnant women exposed to omeprazole found no association with drug use and miscarriage (10).

Does Omeprazole Cause Stillbirth, Preterm Birth, Or Low Birth Weight?

The information available from research to date does not show any added risk of stillbirth, preterm birth, or low birth weight due to omeprazole use during pregnancy (11). According to a recent systematic review, the association of stillbirths or other adverse fetal outcomes with PPI usage in pregnant women was not significant (12).

Can Maternal Exposure To Omeprazole Cause Any Disorder In The Child Later?

Limited incidences are present in current scientific literature. A few studies have shown an association of exposure of pregnant mothers to acid-suppressing drugs with increased risk of childhood asthma in the child. The studies had limitations, and the role of other causative factors could not be ruled out (13)(14)(15).

Can Breastfeeding Mothers Take Omeprazole?

Omeprazole is secreted in breast milk, but if the mother takes 20mg per day, the levels present in milk are unlikely to cause any adverse effects in the baby. Safer drugs include antacids, histamine H2 blockers (famotidine), pantoprazole, and sucralfate. However, you should consult your doctor before starting omeprazole (16).

Proton pump inhibitors, such as omeprazole, are reserved for treating symptoms of GERD when they are not resolved by any other means. Long-term use of PPIs, such as omeprazole, is not recommended in any person as it has been linked to vitamin (B12 and C) and mineral (iron, calcium, magnesium) deficiencies. Long-term suppression of acid release may also increase the risk of intestinal, respiratory, and urinary tract infections (17). Omeprazole is considered safe for short-term use during pregnancy when used after doctor consultation and as per doctor’s prescription.

References:

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  1. Prilosec (omeprazole) Delayed-Release Capsules and Prilosec (omeprazole magnesium) For Delayed-Release Oral Suspension.
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf
  2. Juan C Vazquez et al. (2015)Heartburn in pregnancy.
    https://onlinelibrary.wiley.com/doi/full/10.1111/j.1365-2036.2005.02306.x
  3. Indigestion and heartburn in pregnancy.
    https://www.nhs.uk/pregnancy/related-conditions/common-symptoms/indigestion-and-heartburn/
  4. Omeprazole.
    https://medlineplus.gov/druginfo/meds/a693050.html
  5. Gastroesophageal Reflux Disease (GERD) During Pregnancy.
    https://www.uofmhealth.org/health-library/aa130363
  6. AriehLalkinet. al.The safety of omeprazole during pregnancy: a multicenter prospective controlled study.
    https://pubmed.ncbi.nlm.nih.gov/9757979/
  7. Bjorn Pasternak Use of Proton-Pump Inhibitors in Early Pregnancy and the Risk of Birth Defects.
    https://www.nejm.org/doi/full/10.1056/nejmoa1002689
  8. Lauren B. Gerson (2012)Treatment of Gastroesophageal Reflux Disease During Pregnancy.
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966174/
  9. Antiulcer medicines.
    https://www.who.int/selection_medicines/committees/expert/19/applications/Antiulcers_17_A_R.pdf
  10. Simerpal K. Gill The safety of proton pump inhibitors (PPIs) in pregnancy: a meta-analysis.
    https://pubmed.ncbi.nlm.nih.gov/19491869/
  11. I Matok et al. The safety of fetal exposure to proton-pump inhibitors during pregnancy.
    https://pubmed.ncbi.nlm.nih.gov/22038541/
  12. Cheng Mei Li et al. (2020)
    Systematic review with meta-analysis: the risks of proton pump inhibitors during pregnancy.
  13. Yonghong Zhang et al. (2019)
    Population Scale Retrospective Analysis Reveals Potential Risk of Cholestasis in Pregnant Women Taking Omeprazole
  14. MaayanYitshak-Sade et al.; Prenatal exposure to H2 blockers and to proton pump inhibitors and asthma development in offspring.
    https://pubmed.ncbi.nlm.nih.gov/26096778/
  15. Tianwen Lai et al. Acid-Suppressive Drug Use During Pregnancy and the Risk of Childhood Asthma: A Meta-analysis.
    https://pediatrics.aappublications.org/content/141/2/e20170889.
  16. Drugs and Lactation Database.
    https://www.ncbi.nlm.nih.gov/books/NBK501242/
  17. ArunKoyyada (2021)
    Long-term use of proton pump inhibitors as a risk factor for various adverse manifestations.
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Dr. Joyani Das

Dr. Joyani Das is a PhD in Pharmacology with over two years of experience in academics. Previously, she worked as an associate professor, faculty of Pharmacology. With her research background in preclinical studies and a zeal for scientific writing, she joined MomJunction as a health writer. Her research work was published in international journals and publications, such as Elsevier, Current... more