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Can proton pump inhibitors be used during pregnancy?

Publisher: North West Medicines Information Centre

Keywords: Pregnancy; Rabeprazole; Proton Pump Inhibitors; Lansoprazole; Omeprazole; Pantoprazole;

Date published: 19/01/2012 09:30

Review date: 31/12/2013 00:00

Summary
by: Simone Henderson
  • Most documented exposures to proton pump inhibitors (PPIs) during pregnancy have occurred with omeprazole. Although there is some suggestion from one or two studies that omeprazole may be associated with a slightly higher risk of stillbirths or cardiac malformations, these findings may have occurred by chance.
  • A meta-analysis of seven cohort studies documenting 1,530 exposed pregnancies found that administration of PPIs during the first trimester of pregnancy, and specifically omeprazole, does not pose an important teratogenic risk and concludes that PPIs are a reasonable therapeutic option in pregnancy. This finding was also seen in a cohort study involving 1,800 infants exposed to omeprazole during the first trimester.
  • Although the US Food and Drug Administration (FDA) classifies omeprazole as a higher risk than other PPIs during pregnancy, this is based on results of animal studies. The UK National Teratology Information Service (NTIS) recommends that if a PPI is required during pregnancy, omeprazole should be first choice, as the majority of available data concern this agent and are reassuring. In addition, the Summary of Product Characteristics (SmPC) for omeprazole (Losec®) states that there is sufficient evidence of safety to recommend its use during pregnancy if required.
  • The SmPCs for the other PPIs recommend caution (esomeprazole, pantoprazole), suggest use should be avoided (lansoprazole) or contraindicate use (rabeprazole). If inadvertent exposure to any PPI does occur there is no information to suggest that this represents a major risk.
QA112.4_PPIs_in_pregnancy.doc

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