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

From the Guidelines

Pantoprazole is generally considered safe for use during pregnancy, particularly when the benefits outweigh the potential risks, and is classified as FDA Pregnancy Category B, meaning animal studies show no risk but human studies are limited. The safety of pantoprazole during pregnancy is supported by various studies, including a recent expert review published in Gastroenterology in 2024 1, which suggests that proton pump inhibitors like pantoprazole can be used during pregnancy when necessary.

Key Considerations

• The typical dose of pantoprazole is 40mg once daily, though this may be adjusted based on the specific condition being treated.
• While older antacids and H2 blockers like ranitidine were traditionally preferred as first-line options in pregnancy, proton pump inhibitors like pantoprazole are now commonly prescribed when stronger acid suppression is needed.
• Available data has not shown significant increased risks of birth defects, miscarriage, or adverse pregnancy outcomes with pantoprazole use, but as with any medication during pregnancy, it should only be used when clearly needed and under medical supervision.
• A study published in the European Respiratory Journal in 2020 1 provides a summary of the Therapeutic Goods Administration (TGA) and Food and Drug Administration (FDA) categories for drug use during pregnancy, which can help guide the decision to use pantoprazole during pregnancy.

Comparison with Other Medications

• Other proton pump inhibitors, such as omeprazole, lansoprazole, and esomeprazole, have similar safety profiles during pregnancy, as reported in a study published in the Journal of Hepatology in 2020 1.
• The choice of medication should be based on the individual patient's needs and medical history, as well as the potential risks and benefits of each medication.

Monitoring and Precautions

• Patients taking pantoprazole during pregnancy should be closely monitored for any potential adverse effects, such as headache, diarrhea, or abdominal pain.
• The medication should only be used for the shortest duration necessary to treat the underlying condition, and the patient should be regularly assessed to determine if the medication is still needed.

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.

The safety of pantoprazole during pregnancy is not fully established. While available data from observational studies and animal reproduction studies did not demonstrate an association with major malformations or adverse pregnancy outcomes, methodological limitations of these studies cannot definitely establish or exclude any drug-associated risk during pregnancy.

• Pregnant women should be advised of the potential risk of fetal harm. 2

From the Research

Safety of Pantoprazole During Pregnancy

The safety of pantoprazole, a proton pump inhibitor (PPI), during pregnancy has been evaluated in several studies.

• A study published in 2012 3 suggests that exposure to PPI therapy during pregnancy seems to predispose the fetus to minimal risk.
• Another study published in 2005 4 found that the rate of major congenital anomalies did not differ between pregnant women exposed to pantoprazole and a control group.
• The study 4 compared the pregnancy outcomes of 53 women exposed to pantoprazole with 868 controls and found no significant difference in the rate of major congenital anomalies.

Teratogenic Risk

The teratogenic risk of pantoprazole has been assessed in several studies.

• A study published in 2005 4 found that pantoprazole does not represent a major teratogenic risk in humans.
• The study 4 found that the rate of major congenital anomalies was 2.1% in the pantoprazole group, which is similar to the rate of 3.8% in the control group.

Use of Pantoprazole During Pregnancy

Pantoprazole can be used during pregnancy if medically necessary.

• A study published in 2012 3 suggests that the use of PPI therapy during pregnancy should not be overly restricted based solely on the pregnancy.
• The study 3 recommends that the use of pantoprazole during pregnancy should be discussed with the primary physician if symptomatically necessary.

Comparison with Other Proton Pump Inhibitors

Pantoprazole has been compared with other proton pump inhibitors in terms of safety and efficacy.

• A study published in 2003 5 found that pantoprazole is as effective as other PPIs, such as omeprazole and lansoprazole, in the treatment of acid-related disorders.
• The study 6 found that pantoprazole has an excellent safety profile and is as efficacious as other PPIs.

Special Patient Populations

Pantoprazole has been studied in special patient populations, including the elderly and those with renal or moderate liver disease.

• A study published in 2010 6 found that pantoprazole is safe and effective in these patient populations.
• The study 7 found that pantoprazole is an effective treatment for GERD in the elderly and is associated with high levels of patient satisfaction with therapy.