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:
- The available data from observational studies and animal reproduction studies do not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole.
- However, methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy.
- It is recommended to advise pregnant women of the potential risk of fetal harm. 1
From the Research
Pantoprazole is generally considered safe to use during pregnancy when medically necessary, though it should be used with caution and under a healthcare provider's supervision. The most recent and highest quality study on this topic is from 2009, which found that proton pump inhibitors, including pantoprazole, are not associated with an increased risk of major congenital birth defects, spontaneous abortions, or preterm delivery 2. This study, a meta-analysis published in The American Journal of Gastroenterology, analyzed data from 134,940 patients, including 1,530 exposed to proton pump inhibitors, and found an overall odds ratio for major malformations of 1.12 (95% confidence interval, 0.86-1.45) 2. Key points to consider when prescribing pantoprazole during pregnancy include:
- The typical dose is 40 mg once daily, though this may vary based on the condition being treated
- Lifestyle modifications, such as eating smaller meals, avoiding trigger foods, not eating close to bedtime, and elevating the head while sleeping, should be tried first
- Pantoprazole works by reducing stomach acid production by blocking the proton pump in gastric parietal cells
- Any medication use during pregnancy should be discussed with an obstetrician or healthcare provider who can evaluate individual circumstances and risk factors It's also worth noting that while pantoprazole appears to have minimal placental transfer, the safety of its use during pregnancy should be carefully evaluated, especially in light of a 2010 study published in The New England Journal of Medicine, which found a slightly increased risk of major birth defects associated with exposure to proton pump inhibitors during the first trimester of pregnancy, although this risk was not statistically significant when limited to exposure during the first trimester 3. However, the 2009 meta-analysis provides stronger evidence for the safety of proton pump inhibitors during pregnancy, and pantoprazole can be considered a safe option when medically necessary.