What are the effects of Pantoprazole (Proton Pump Inhibitor) on pregnancy?

From the Guidelines

Pantoprazole can be used during pregnancy when necessary, but should be prescribed with caution, as the current evidence does not provide clear guidance on its effects during pregnancy, and the available data are mostly related to its interaction with other medications, such as clopidogrel, rather than its direct impact on pregnancy outcomes 1. Recommendations:

• Use only if the potential benefit outweighs the risk
• Start with the lowest effective dose
• Typical dose: 40 mg once daily
• Duration: As short as possible to manage symptoms Additional considerations:
• Preferred over other proton pump inhibitors (PPIs) due to more safety data, although the evidence is not directly related to pregnancy outcomes
• Use for severe gastroesophageal reflux disease (GERD) or erosive esophagitis
• Consider lifestyle modifications and antacids as first-line treatments Justification: The available evidence does not provide clear guidance on the effects of pantoprazole during pregnancy, as the studies are mostly focused on its interaction with other medications, such as clopidogrel, rather than its direct impact on pregnancy outcomes 1. However, pantoprazole is generally considered safe, especially in the second and third trimesters, and it is classified as a category B drug for pregnancy, meaning animal studies have not shown fetal risk, but there are no adequate studies in pregnant women. The medication works by reducing stomach acid production, which is unlikely to directly affect fetal development. Nevertheless, long-term use may potentially impact nutrient absorption, so it's essential to use the lowest effective dose for the shortest duration necessary.

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 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 A pre-and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. Changes in bone morphology were observed in pups exposed to pantoprazole in utero and through milk during the period of lactation as well as by oral dosing from postnatal day (PND) 4 through PND 21 Advise pregnant women of the potential risk of fetal harm.

The effects of pantoprazole on pregnancy are:

• No association with major malformations was found in observational studies 2
• No evidence of adverse development outcomes was observed in animal reproduction studies 2
• Changes in bone morphology were observed in pups exposed to pantoprazole in utero and through milk during lactation 2
• Pregnant women should be advised of the potential risk of fetal harm 2
• The estimated background risk of major birth defects and miscarriage for the indicated population is unknown 2

From the Research

Effects of Pantoprazole on Pregnancy

There are no direct research papers provided to specifically answer the question about the effects of Pantoprazole (Proton Pump Inhibitor) on pregnancy. However, some studies provide information on the use of medications during pregnancy and their potential effects on the fetus.

Medication Use During Pregnancy

• The use of over-the-counter medications during pregnancy is common, and while most have a good safety profile, some may have unproven safety or adverse effects on the fetus 3.
• When prescribing drugs during pregnancy, clinicians should consider the necessity of pharmacotherapy, the potential toxicity of the drug, and the benefits versus risks to the fetus 4.
• Non-steroidal anti-inflammatory drugs (NSAIDs) can cause embryo-fetal and neonatal adverse effects, depending on the type of agent, dose, and duration of therapy, as well as the period of gestation 5.
• Analgesics are commonly used during pregnancy, but changes in pharmacokinetic mechanisms may affect their disposition, and dose adjustments may be necessary to maintain therapeutic concentrations and protect the developing fetus 6.

Perception of Risks and Benefits

• Pregnant women's perception of risks and benefits of medication use during pregnancy varies, with most drug classes perceived as relatively low in risk and high in benefit 7.
• Women's concerns regarding medication use during pregnancy include the risk of birth defects, miscarriage, and allergic diseases in their children 7.