Merasal Use In Pregnancy & Lactation

Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Although no studies have investigated the association of PPHN to mirtazapine treatment, this potential risk cannot be ruled out taking into account the related mechanism of action (increase in serotonin concentrations).
There are no adequate data from the use of mirtazapine in pregnant women. Studies in animals have not shown any teratogenic effect or reproductive toxicity of clinical relevance (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown. Mirtazapine should not be used during pregnancy unless clearly indicated following a careful clinical risk/benefit consideration.
Although animal experiments show that mirtazapine is excreted only in very small amounts in the milk, the use of mirtazapine in breast-feeding mothers is not recommended. No human data is available.