USE OF DULOXETINE IN PREGNANCY

Duloxetine is a serotonin noradrenaline re-uptake inhibitor (SNRI) indicated for the treatment of major depressive disorder, diabetic peripheral neuropathic pain, generalised anxiety disorder, and for the treatment of moderate-to-severe urinary stress incontinence.

The data on duloxetine exposure in pregnancy do not suggest increased risks of congenital malformation overall or cardiac defects specifically, miscarriage, stillbirth, fetal growth impairment, or preterm delivery. Increased risks of poor neonatal adaptation have been observed following third trimester exposure.

Although there are no published data which identify an increased risk of persistent pulmonary hypertension of the newborn (PPHN) with maternal duloxetine use, SNRIs share similar mechanistic properties with SSRIs which are associated with an increased risk of PPHN following use in pregnancy. The possibility of an increased risk of PPHN in the neonate should therefore be considered, particularly as other neonatal problems similar to those reported with SSRIs have also been observed in infants exposed to SNRIs in utero. These include respiratory problems, low Apgar score, hypoglycaemia and convulsions. Infants exposed to antidepressants in utero should ideally be delivered in a unit with neonatal support and the delivery team made aware of the exposure. The neonate should be monitored for adverse effects post-delivery.

It is important to ensure that mental health conditions are treated appropriately. As such, duloxetine may be suitable for use in pregnancy following an individualised assessment of the risks and benefits. Where clinically appropriate, non-pharmaceutical management of depression and/or anxiety could be considered during pregnancy. However, where a patient is stabilised on duloxetine, either prior to conception or during pregnancy, the risk of discontinuing treatment, changing the medication or reducing the dose, should be carefully weighed against the risk of maternal relapse. In cases where treatment with duloxetine is continued in pregnancy, the lowest effective dose should be used.

Exposure to duloxetine at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.