Can a pregnant woman take a Proton Pump Inhibitor (PPI)?

From the Guidelines

Pregnant women can take a Proton Pump Inhibitor (PPI) if necessary, as stated in the guidelines based on a third international consensus meeting 1. The use of PPIs during pregnancy should be based on the benefits outweighing the risks, and medical supervision is recommended. According to the guidelines, medications like metoclopramide, 5HT3 antagonists, ranitidine, proton pump inhibitors, methylprednisolone, prednisolone, or hydrocortisone can be used if necessary 1.

When considering the use of PPIs during pregnancy, it's essential to weigh the potential benefits against the risks. The guidelines suggest that chemotherapy, which may involve the use of PPIs as supportive medication, can be administered after 14 weeks of gestation, but not beyond 35 weeks 1. However, this information is more relevant to cancer treatment during pregnancy rather than the general use of PPIs for conditions like heartburn or GERD.

In the context of using PPIs for common conditions like heartburn or GERD, the approach typically involves starting with lifestyle modifications and considering the use of antacids or H2 blockers before prescribing a PPI. If a PPI is necessary, it should be used at the lowest effective dose for the shortest duration needed. The safety profile of PPIs during pregnancy is generally reassuring, with no consistent evidence of increased risk for birth defects or adverse pregnancy outcomes, as observed in observational studies 1.

Key points to consider when prescribing PPIs to pregnant women include:

• The use of PPIs should be medically supervised.
• Lifestyle modifications should be considered first for conditions like heartburn or GERD.
• Antacids or H2 blockers may be suggested before prescribing a PPI.
• PPIs should be used at the lowest effective dose for the shortest duration necessary.
• Each pregnancy is unique, and the benefits and risks of PPI use should be weighed on an individual basis 1.

From the FDA Drug Label

Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. In the U. S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively

Pregnancy and PPI Use:

• There are no adequate and well-controlled studies with omeprazole in pregnant women.
• Epidemiologic data do not demonstrate an increased risk of major congenital malformations with first trimester omeprazole use.
• The background risk of major birth defects and miscarriage in the general population is estimated to be 2-4% and 15-20%, respectively.
• Key Considerations: + No increased risk of major congenital malformations has been demonstrated. + Background risks of birth defects and miscarriage apply to all pregnancies.
• Clinical Decision: A pregnant woman can take a Proton Pump Inhibitor (PPI) like omeprazole, but this should be done under the guidance of a healthcare provider, weighing the potential benefits and risks 2, 3.

From the Research

Proton Pump Inhibitors (PPIs) During Pregnancy

• PPIs can be used during pregnancy, but with certain considerations 4, 5, 6, 7, 8.
• The treatment of gastroesophageal reflux disease (GERD) during pregnancy should follow a step-up approach, starting with lifestyle modifications and antacids, and progressing to histamine-2 receptor antagonists and PPIs if necessary 4, 5, 6.
• PPIs, except omeprazole, can be given after the first trimester, considering the benefit-harm ratio for the mother and fetus 4.
• Studies have shown that PPIs are not associated with an increased risk of major congenital birth defects, spontaneous abortions, or preterm delivery 7.
• Omeprazole is not considered teratogenic in humans, and limited information on other PPIs suggests that they are also not teratogenic 8.

Safety of PPIs During Pregnancy

• A meta-analysis of 7 studies found no increased risk of major malformations, spontaneous abortions, or preterm delivery associated with PPI use during pregnancy 7.
• The overall odds ratio for major malformations was 1.12 (95% confidence interval: 0.86-1.45) 7.
• The use of PPIs during pregnancy should be discussed with the primary physician if symptomatically necessary 5.

Treatment Recommendations

• The preferred choice of antacids is calcium-containing antacids 6.
• If symptoms persist with antacids, sucralfate can be introduced, followed by histamine-2 receptor antagonists 6.
• Inadequate control while on histamine-2 receptor antagonist and antacid may mandate a step-up to PPIs along with antacids as rescue medication for breakthrough GERD 6.