Is Pantoloc (Pantoprazole) safe during pregnancy?

From the Guidelines

Pantoloc (pantoprazole) should be avoided in pregnancy unless absolutely necessary, due to the potential risks to the fetus and the availability of alternative treatments for constipation and other gastrointestinal issues. The most recent and highest quality study on pregnancy-related gastrointestinal and liver disease, published in 2024 in the journal Gastroenterology 1, provides guidance on the management of constipation in pregnant persons. According to this study, treatment options for constipation in pregnancy include dietary fiber, lactulose, and polyethylene glycol–based laxatives.

Some key points to consider when managing constipation in pregnancy include:

• Increasing dietary fiber intake to the recommended daily amount of approximately 30 g/d to promote regular bowel movements and prevent constipation
• Consuming an adequate amount of fluids, particularly water, to help soften stools and ease bowel movements
• Using bulk-forming agents, such as psyllium husk or methylcellulose, which are safe to administer in pregnancy due to the lack of systemic absorption
• Avoiding stimulant laxatives, as safety data on these medications are conflicting
• Considering the use of osmotic laxatives, such as polyethylene glycol or lactulose, which can be administered safely during pregnancy, but may cause maternal bloating.

In terms of medication use, it is essential to weigh the potential benefits and risks of using Pantoloc (pantoprazole) during pregnancy, and to consider alternative treatments that may be safer and more effective. As the study published in Gastroenterology notes, the increased levels of progesterone during pregnancy can slow GI motility, leading to constipation, and other medications, such as lactulose, may be more suitable for managing this condition 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.

Pantoloc (Pantoprazole) 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 2.
• The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
• Key Considerations:
  • No increased risk of major malformations or spontaneous abortion was found in studies.
  • Animal studies showed no evidence of adverse development outcomes.
  • Pregnant women should be advised of the potential risk of fetal harm.

From the Research

Pantoloc in Pregnancy

There are no research papers provided that directly discuss the use of Pantoloc (pantoprazole) in pregnancy.

Available Information on Pantoprazole

• The provided studies discuss the efficacy and safety of pantoprazole in treating various acid-related disorders, such as gastroesophageal reflux disease (GERD) and peptic ulcer disease 3, 4, 5, 6, 7.
• Pantoprazole has been shown to be effective in healing and preventing relapse of GERD symptoms, as well as in eradicating Helicobacter pylori infection when used in combination with antimicrobial agents 3, 7.
• The studies compare pantoprazole with other proton pump inhibitors (PPIs), such as omeprazole and lansoprazole, and with histamine H2-receptor antagonists, such as ranitidine 4, 6, 7.
• Pantoprazole has been found to be well-tolerated and to have a similar safety profile to other PPIs 3, 4.

Key Findings

• Pantoprazole is effective in treating GERD symptoms, with significant relief from heartburn and acid regurgitation observed in clinical trials 4, 5, 6.
• Pantoprazole has been shown to be superior to ranitidine in controlling GERD symptoms 4, 6.
• The onset of symptom relief with pantoprazole is rapid, with significant relief observed as early as day 2 of treatment 5.