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. Therapeutic doses of omeprazole in pregnancy are unlikely to increase teratogenic risk. Omeprazole is a drug classified under proton pump inhibitor (PPI) drugs. It is indicated for treating heartburn and other symptoms of gastroesophageal reflux disorder (GERD) in adults and children. Additionally, it is used to treat duodenal ulcers and is combined with antibiotics, clarithromycin, and amoxicillin to treat Helicobacter pylori infection. Other conditions treated with omeprazole include gastric, erosive esophagitis and stomach acid hypersecretion disorders such as Zollinger Ellison syndrome and multiple endocrine tumors (1). Read on to understand the use of omeprazole during pregnancy and whether it is safe for the mother and 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).
