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Dyspepsia - pregnancy-associated - Management
What issues should I consider before prescribing omeprazole?
- Omeprazole is licensed for use in pregnancy [ABPI Medicines Compendium, 2008] and is likely to be safe for use in all trimesters:
- The British National Formulary states it is 'not known to be harmful (in pregnancy)' [BNF 54, 2007].
- It is considered to be a class C drug in pregnancy by the United States Food and Drug Administration (i.e. 'Animal studies show risk but human studies are inadequate or no studies in humans or animals'). This is in contrast to the other proton pump inhibitors (namely esomeprazole, lansoprazole, pantoprazole, and rabeprazole), which are all class B [Madanick and Katz, 2006]. However, this classification is based on animal studies where very high doses were found to be teratogenic; recent evidence from observational studies in humans show that the drug is unlikely to be harmful to the fetus.
- CKS recommends the use of standard doses of omeprazole as used for other people with acid reflux disease, as there is an absence of evidence on dosage in pregnancy from controlled trials [ABPI Medicines Compendium, 2008]. This is a relatively conservative regimen, using low doses. The maximal effect develops after 5 days [Christopher, 2005].
- The starting dose is 10 mg, once a day [Christopher, 2005].
- This can be increased to 20 mg, once a day, if symptoms are not fully improved after 5 days or if they return.
- If symptoms persist, seek specialist advice.
- Omeprazole is well tolerated. The most common adverse effects are headache or gastrointestinal effects (e.g. diarrhoea), including symptoms often seen in pregnancy (e.g. nausea and vomiting). It therefore may not be clear if it is the drug that is causing these adverse effects [ABPI Medicines Compendium, 2008]. If in doubt, stop the drug, and seek specialist advice if symptoms are severe or persistent.
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