From the FDA Drug Label
There are no adequate and well-controlled studies with omeprazole in pregnant women. The FDA drug label does not answer the question.
From the Research
Omeprazole is classified as pregnancy category C by the FDA, and its use during pregnancy is generally considered acceptable, especially after the first trimester, when the benefit outweighs the risk. This classification is based on animal studies that have shown adverse effects on the fetus, but there are no adequate well-controlled studies in humans 1. However, potential benefits may warrant use of omeprazole during pregnancy despite potential risks.
Key Considerations
- If omeprazole is needed during pregnancy, it's generally considered acceptable to use, especially after the first trimester when the benefit outweighs the risk.
- For pregnant women requiring treatment for acid-related disorders, lifestyle modifications should be tried first, followed by antacids or sucralfate.
- If these are insufficient, H2-blockers like ranitidine are typically preferred as first-line medication therapy before considering proton pump inhibitors like omeprazole.
- The classification reflects a cautious approach rather than proven harm, as real-world experience with omeprazole in pregnancy has not demonstrated significant adverse outcomes, as shown in a multicentre prospective controlled study 1.
Clinical Decision Making
Healthcare providers should always evaluate the individual clinical situation when prescribing omeprazole during pregnancy, considering the potential benefits and risks. A study published in 2005 found that the rate of major congenital anomalies did not differ between women exposed to omeprazole and a control group 1. This suggests that omeprazole may be safer than previously thought, but more research is needed to confirm this.
Summary of Evidence
- A multicentre prospective controlled study found that the rate of major congenital anomalies did not differ between women exposed to omeprazole and a control group 1.
- Another study found that omeprazole is well tolerated and does not cause severe side effects in pregnant women or their newborns 2.
- A record-linkage analysis in Tayside, Scotland, found that prescribing of Category C drugs, including omeprazole, was common during pregnancy, but the levels of prescribing of drugs that are known to be harmful were low 3.