Revised SPC: Cymbalta (duloxetine) hard gastro-resistant capsules

The pregnancy section has been updated with data from two large observational studies (one EU and one US); these do not suggest an overall increased risk of major congenital malformation, but the analysis on specific malformations is inconclusive.

SPS commentary:

In one of these studies, maternal exposure to duloxetine during late pregnancy (at any time from 20 weeks gestational age to delivery) was associated with an increased risk for preterm birth (corresponding to approximately 6 additional premature births per 100 women treated with duloxetine late in pregnancy). The majority occurred between 35 and 36 weeks of gestation. This association was not seen in the US study.

The US observational data have provided evidence of an increased risk (less than 2 -fold) of postpartum haemorrhage following duloxetine exposure within the month prior to birth.


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