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Dyspepsia - pregnancy-associated - Management
What issues should I consider before prescribing ranitidine?

  • Ranitidine is not licensed for use in pregnant women, but is considered safe on the basis of several years of use without incident, and supporting evidence from observational studies.
    • The British National Formulary (BNF) states 'Manufacturer advises avoid unless essential, but not known to be harmful' [BNF 54, 2007]. This is in accordance with the product license stated in the Summary of Product Characteristics [ABPI Medicines Compendium, 2009].
    • It is classed as a group B drug in terms of risk to pregnancy by the United States Food and Drug Administration (i.e. 'animal studies shown no risk but human studies inadequate or animal studies show some risk not supported by human studies') [Ali and Egan, 2007].
  • CKS recommends the usual dosage of ranitidine; 150 mg, twice a day [Schaefer et al, 2007]. This is consistent with an RCT which found a lower dosage (150 mg, once a day) to be ineffective [Larson et al, 1997]. If this dosage provides insufficient protection, consider switching to omeprazole or seeking specialist advice.
  • Ranitidine is well tolerated by most women. Some adverse effects were reported following post-marketing surveillance (rather than data from controlled trials, so they were not necessarily causal associations) and are estimated to occur rarely (affecting less than one person in 1000) [ABPI Medicines Compendium, 2009].

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