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Limited data of the use of mirtazapine in pregnant women do not indicate an increased risk for congenital malformations. Studies in animals have not shown any teratogenic effects of clinical relevance, however developmental toxicity has been observed (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). Caution should be exercised when prescribing to pregnant women. If Remeron is used until, or shortly before birth, postnatal monitoring of the newborn is recommended to account for possible discontinuation effects.
Animal studies and limited human data have shown excretion of mirtazapine in breast milk only in very small amounts. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Remeron should be made taking into account the benefit of breast-feeding to the child and the benefit of Remeron therapy to the woman.
