From the FDA Drug Label
8 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 intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 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 Advise pregnant women of the potential risk of fetal harm.
Pantoprazole use in pregnancy:
- Available data from observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole.
- Animal reproduction studies showed no evidence of adverse development outcomes.
- Pregnant women should be advised of the potential risk of fetal harm. Based on the available data, inj pantop can be given in pregnancy, but with caution and advising pregnant women of the potential risk of fetal harm 1.
From the Research
Pantoprazole injection (Inj Pantop) can be used during pregnancy when the benefits outweigh the risks, particularly in cases of severe gastroesophageal reflux disease (GERD), peptic ulcers, or other conditions requiring acid suppression that cannot be managed with safer alternatives. When considering the use of pantoprazole during pregnancy, it is essential to weigh the potential benefits against the risks. The most recent and highest quality study, 2, although not directly addressing the use of pantoprazole in pregnancy, highlights the importance of judicious use of proton pump inhibitors (PPIs) like pantoprazole, emphasizing the need to limit treatment duration to minimize adverse effects.
Key Considerations
- Pantoprazole is classified as FDA pregnancy category B, meaning animal studies have not shown fetal risk but there are limited well-controlled studies in pregnant women 3.
- The typical dose of pantoprazole injection is 40mg intravenously once daily, and treatment should be limited to the shortest duration possible.
- Non-pharmacological approaches like dietary modifications and lifestyle changes should be tried first.
- Oral antacids are generally considered safer first-line options during pregnancy.
Decision Making
The decision to use pantoprazole injection during pregnancy should be made in consultation with a healthcare provider who can evaluate the individual clinical situation and weigh potential benefits against risks for both mother and fetus. Given the lack of direct evidence on the use of pantoprazole in pregnancy from the provided studies, the approach should be cautious, prioritizing the use of safer alternatives when possible and minimizing treatment duration when pantoprazole is deemed necessary.