What is the pregnancy category of Pantoprazole (Proton Pump Inhibitor)?

From the Guidelines

Pantoprazole is classified as a pregnancy category B medication, which means animal studies have not shown a risk to the fetus, but there are no adequate well-controlled studies in pregnant women. This classification is based on the US Food and Drug Administration classification system, as described in the European Heart Journal study 1. The following key points are relevant to the use of pantoprazole during pregnancy:

• Category B classification indicates that either animal reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women.
• Pantoprazole is a proton pump inhibitor (PPI) that reduces stomach acid production and is commonly prescribed for conditions like gastroesophageal reflux disease (GERD), peptic ulcers, and other acid-related disorders.
• If pantoprazole is needed during pregnancy, it should be used at the lowest effective dose for the shortest duration necessary, as recommended by healthcare providers who can weigh individual risks and benefits. Some key considerations for the use of pantoprazole during pregnancy include:
• The medication works by blocking the enzyme system responsible for acid secretion in the stomach, providing relief from acid-related symptoms.
• Any medication use during pregnancy should be discussed with a healthcare provider who can assess individual risks and benefits, as described in the study 1.
• The typical adult dose is 40 mg once daily, though this may vary based on the condition being treated. It is essential to note that while pantoprazole is generally considered safe, the potential benefits and risks should be carefully evaluated by a healthcare provider before initiating treatment during pregnancy, as indicated in the study 1.

From the FDA Drug Label

1. 1 Pregnancy Teratogenic Effects Pregnancy Category C Reproduction studies have been performed in rats at oral pantoprazole doses up to 450 mg/kg/day (about 88 times the recommended human dose based on body surface area) and in rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose based on body surface area) with administration of pantoprazole sodium during organogenesis in pregnant animals. The studies have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. There are no adequate and well-controlled studies in pregnant women. Advise pregnant women of the potential risk of fetal harm. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The pregnancy category of Pantoprazole is Category C.

• Key points:
  • No evidence of impaired fertility or harm to the fetus in animal studies
  • No adequate and well-controlled studies in pregnant women
  • Potential risk of fetal harm exists
  • Use during pregnancy only if potential benefit justifies potential risk to the fetus 2

From the Research

Pregnancy Category of Pantoprazole

The pregnancy category of Pantoprazole, a proton pump inhibitor, is not explicitly stated in the provided studies. However, the studies discuss the classification systems for drug use during pregnancy:

• The Swedish system for the classification of fetal risk of drugs, which includes categories A to D, is described in 3 and 4.
• The US Food and Drug Administration (FDA) system, which also uses categories A to D, as well as an X category, is mentioned in 4.

Classification Systems

The studies explain the definitions of the categories in the Swedish system:

• Category A: Drugs that have been extensively used and have shown no evidence of disturbance of the reproductive process 3, 4.
• Category B: Drugs for which data from pregnant women are insufficient, and classification is based on animal data 3, 4.
• Category C: Drugs that may have undesirable effects on the human fetus or newborn infant 3, 4.
• Category D: Drugs that have caused an increased incidence of malformations or other permanent damage in humans 3, 4.

Pantoprazole Studies

The studies 5, 6, 7 discuss the pharmacological properties and therapeutic use of pantoprazole in acid-related disorders, but do not provide information on its pregnancy category.

Conclusion Not Available

There are no research papers provided that directly answer the question of the pregnancy category of Pantoprazole.