Paroxetine Pregnancy — MRCPsych Paper B MCQ

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ModeratePerinatal PsychiatryParoxetine PregnancyMRCPsych Paper B

A 27-year-old woman with recurrent depressive disorder, currently in remission on an antidepressant, attends a preconception clinic and asks about first-trimester risks. For which one of the following antidepressants does the UK Summary of Product Characteristics specifically state that first-trimester exposure has been associated with an increased risk of congenital malformations, particularly cardiovascular defects such as ventricular and atrial septal defects?

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Correct answer: C — Paroxetine

Paroxetine is correct. Its UK SmPC states that epidemiological studies suggest an increased risk of congenital malformations, particularly cardiovascular defects such as ventricular and atrial septal defects, following first-trimester exposure. The estimated absolute cardiovascular-defect risk is under 2/100, compared with a background risk of about 1/100. Fluoxetine is the strongest distractor because its SmPC also reports a cardiovascular-defect signal of approximately 2/100; therefore, the original claim that paroxetine has the definitively highest risk was not supportable. However, the specific named septal-defect statement identifies paroxetine. Sertraline and citalopram SmPCs do not report an induced malformation signal, while venlafaxine has inadequate human pregnancy data and recognised neonatal discontinuation risks. NICE advises individualised risk–benefit assessment based on previous response, relapse risk and reproductive safety; treatment should not be switched automatically or stopped abruptly.

Reference: electronic Medicines Compendium (UK), Paroxetine 20mg Tablets — Summary of Product Characteristics, section 4.6 Fertility, pregnancy and lactation, revised 20 May 2026. https://www.medicines.org.uk/emc/product/537/smpc