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Animal studies have revealed no evidence of teratogenic effects or fetal toxicity due to mesalazine. Limited clinical studies on the use of mesalazine in pregnancy have shown no detrimental effect on gestation and fetal outcome.
Low concentrations of mesalazine and its N-acetyl metabolite have been detected in human breast milk. Whilst the clinical significance of this has not been determined, caution should be exercised when mesalazine is administered to a nursing mother.
The use of mesalazine during pregnancy and lactation should be restricted to those cases where in the physician's opinion potential benefits from this therapy outweigh potential risks.
