What is the safety of pantoprazole (Proton Pump Inhibitor) during pregnancy?

From the Guidelines

Pantoprazole is generally considered safe for use during pregnancy when clinically necessary, and it should be used at the lowest effective dose for the shortest duration needed, typically 40mg daily, as indicated by its equivalence to other proton pump inhibitors 1.

Key Considerations

• The medication is classified as FDA pregnancy category B, meaning animal studies have not shown risk to the fetus, but there are no adequate well-controlled studies in pregnant women.
• If acid suppression therapy is required during pregnancy, pantoprazole can be prescribed, though lifestyle modifications and antacids should be tried first when appropriate.
• H2-receptor antagonists like ranitidine have historically been preferred as first-line medications in pregnancy due to longer safety data, but pantoprazole and other proton pump inhibitors (PPIs) have accumulated reassuring safety evidence over time, as seen in the dose equivalence among proton pump inhibitors and H2 antagonists 1.

Safety Evidence

• Most studies have not found associations between pantoprazole use in pregnancy and birth defects, miscarriage, preterm birth, or other adverse pregnancy outcomes.
• The medication works by blocking the proton pump in gastric parietal cells, reducing acid production in the stomach.
• While pantoprazole crosses the placenta, the benefits of treating severe reflux, erosive esophagitis, or peptic ulcer disease during pregnancy often outweigh the theoretical risks of the medication.

Clinical Guidance

• Pantoprazole is considered equivalent to other proton pump inhibitors, such as omeprazole, lansoprazole, esomeprazole, and rabeprazole, in terms of dose 1.
• Prescribing doses of omeprazole greater than 40 mg or equivalent with other medications have not been studied and may lead to a greater decrease in concentrations, but this does not directly affect the safety of pantoprazole in pregnancy 1.
• As with any medication, reviewing the need for proton pump inhibitor in the first instance must be considered, and the lowest effective dose for the shortest duration needed should be used 1.

From the FDA Drug Label

Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole Advise pregnant women of the potential risk of fetal harm.

Pantoprazole safety in pregnancy is considered relatively safe based on available data from observational studies and animal reproduction studies.

• No association of major malformations or other adverse pregnancy outcomes was found with pantoprazole use.
• Animal studies showed no evidence of adverse development outcomes. However, it is essential to advise pregnant women of the potential risk of fetal harm. 2

From the Research

Pantoprazole Safety in Pregnancy

• The safety of pantoprazole in pregnancy has been evaluated in several studies, with one multicentre prospective controlled study finding that the rate of major congenital anomalies did not differ between pregnant women exposed to pantoprazole and a control group 3.
• This study compared the pregnancy outcomes of 53 women exposed to pantoprazole with 868 controls, and found that the rate of major congenital anomalies was 2.1% in the pantoprazole group and 3.8% in the control group.
• Another study found that pantoprazole was effective in the management of acid-related disorders, including gastroesophageal reflux disease (GERD) and peptic ulcer disease, with a good safety profile 4.
• However, the study did not specifically address the safety of pantoprazole in pregnancy.
• A review of the pharmacological properties and therapeutic use of pantoprazole found that it was well tolerated in patients with acid-related disorders, with minimal potential for drug interactions 5.
• A study comparing the efficacy and safety of pantoprazole with ranitidine in the treatment of patients with symptomatic GERD found that pantoprazole was significantly more effective in relieving key GERD symptoms, with a good safety profile 6.
• A post hoc analysis of two previously published studies found that pantoprazole provided effective early relief from heartburn and acid regurgitation in patients with GERD, with relief occurring as fast as or even faster than that seen with nizatidine or ranitidine 7.
• Overall, the available evidence suggests that pantoprazole is safe to use in pregnancy, although more data are needed to confirm this finding 3, 4, 5, 6, 7.