Is Protonix (pantoprazole) safe to use during pregnancy?

From the Guidelines

Pantoprazole (Protonix) is generally considered safe during pregnancy when medically necessary, though it should be used with caution. It is classified as FDA pregnancy category B, meaning animal studies have not shown risk to the fetus, but there are limited well-controlled studies in pregnant women 1. If you need treatment for acid-related conditions during pregnancy, pantoprazole may be prescribed, typically at the standard dose of 40 mg once daily. However, it should only be used when the potential benefits outweigh the possible risks. Some key points to consider when using pantoprazole during pregnancy include:

• Lifestyle modifications should be tried first, such as eating smaller meals, avoiding trigger foods, and not lying down after eating.
• The safety profile of pantoprazole is based on its minimal crossing of the placental barrier and limited data showing no increased risk of major birth defects or adverse pregnancy outcomes 1.
• You should always consult with your healthcare provider before taking any medication during pregnancy, as they can evaluate your specific situation and recommend the most appropriate treatment option. It's also important to note that the FDA pregnancy categories are as follows:
• Category A: Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimesters) and the possibility of fetal harm appears remote.
• Category B: Either animal reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).
• Category C: Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available.
• Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g. if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
• Category X: Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. Pantoprazole falls under category B, which suggests that it can be used during pregnancy if the benefits outweigh the risks 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.

The use of Protonix (pantoprazole) during pregnancy is considered relatively safe based on available data from observational studies and animal reproduction studies. However, it is essential to note that:

• Methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy.
• Pregnant women should be advised of the potential risk of fetal harm.
• The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Key points to consider:
• No association of major malformations or other adverse pregnancy outcomes with pantoprazole was found in observational studies.
• Animal reproduction studies showed no evidence of adverse development outcomes with pantoprazole. It is crucial to weigh the potential benefits and risks of using Protonix during pregnancy, and pregnant women should consult their healthcare provider to discuss the risks and benefits 2.

From the Research

Protonix Safety During Pregnancy

• The safety of Protonix (pantoprazole) during pregnancy has been evaluated in several studies 3, 4, 5.
• A 2023 cohort study published in JAMA Network Open found that the use of proton pump inhibitors (PPIs) during early pregnancy was not associated with a substantial increase in the risk of congenital malformations, although small increased risks were observed for major congenital malformations and congenital heart defects 3.
• A 2012 review published in Drugs stated that exposure to PPI therapy during pregnancy seems to predispose the fetus to minimal risk, and these medications should be discussed with the primary physician if symptomatically necessary in the pregnant patient 4.
• A 2010 cohort study published in The New England Journal of Medicine found that exposure to PPIs during the first trimester of pregnancy was not associated with a significantly increased risk of major birth defects 5.

Key Findings

• The absolute risk of major congenital malformations was 396.7 per 10,000 infants in PPI-exposed pregnancies and 323.4 per 10,000 infants in unexposed pregnancies 3.
• The propensity score-adjusted relative risks were 1.07 (95% CI, 1.02-1.13) for major congenital malformations and 1.09 (95% CI, 1.01-1.17) for congenital heart defects 3.
• The use of PPIs during pregnancy should be discussed with the primary physician if symptomatically necessary, as the benefits of treatment may outweigh the potential risks 4.

Study Limitations

• The studies had limitations, including the potential for confounding variables and the reliance on observational data 3, 5.
• Further research is needed to fully understand the safety of Protonix during pregnancy 3, 4, 5.