From the FDA Drug Label
- Use in Specific Populations 8. 1 Pregnancy Risk Summary 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 Reproduction studies have been performed in rats at oral doses up to 450 mg/kg/day (about 88 times the recommended human dose) and rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose) with administration of pantoprazole during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to pantoprazole in this study
Pantoprazole is likely safe for use during pregnancy. The available data from published observational studies and animal reproduction studies do not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. However, it is essential to note that:
- Methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy.
- Advise pregnant women of the potential risk of fetal harm.
- The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Based on the information provided in the drug label 1, pantoprazole can be used during pregnancy, but with caution and under the guidance of a healthcare provider.
From the Research
Pantoprazole is generally considered safe during pregnancy when medically necessary, though it should be used with caution. The safety profile of pantoprazole is based on its minimal placental transfer and lack of evidence suggesting harmful effects on fetal development, as supported by a multicentre prospective controlled study published in 2005 2. This study found that the rate of major congenital anomalies did not differ between pregnant women exposed to pantoprazole and a control group.
When considering the use of pantoprazole during pregnancy, it is essential to weigh the potential benefits against the risks, as outlined in a study published in 1998 3. The study emphasizes the importance of prescribing medication with a long safety record, avoiding exposure in the first trimester, avoiding multidrug regimens, and prescribing the lowest dose for the shortest duration to minimize fetal risk.
Some key points to consider when using pantoprazole during pregnancy include:
- Using the lowest effective dose for the shortest duration necessary
- Trying lifestyle modifications first, such as avoiding trigger foods, eating smaller meals, not lying down after eating, and elevating the head of the bed
- Consulting with a healthcare provider to weigh the potential benefits against risks for the specific situation
- Being aware that while pantoprazole is considered safe, there are no adequate well-controlled studies in pregnant women, as noted in various studies, including one published in 2016 4 and another in 2006 5.
It is crucial to consult with a healthcare provider before taking any medication during pregnancy, as they can provide personalized guidance and recommendations based on the individual's specific situation and medical history.