PARLIAMENTARY WRITTEN QUESTION
Mirtazapine: Pregnancy (13 July 2022)

While there is currently limited data on the use of mirtazapine in pregnant women, the data available do not indicate an increased risk of congenital malformations. Caution is advised when used during pregnancy, particularly as until or shortly before the birth, the baby should be monitored for any possible side effects relating to withdrawal or toxicity.

The product information also includes information about the potential risk of persistent pulmonary hypertension of the newborn, which is known to be associated with the use of some antidepressants with a similar mechanism of action as mirtazapine.

The safety of mirtazapine use in pregnancy is continually monitored and assessed through the periodic review of the latest available data from scientific studies and side effects reported through the Yellow Card Scheme. The product information is updated in response to these ongoing data assessments to reflect the most up to date advice for patients and prescribers.