Fluoxetine: possible link to foetal cardiac defects

Infants exposed to fluoxetine during early gestation may have a slightly increased risk of congenital cardiac defects, the MHRA has advised. The increased risk, estimated to affect fewer than 2 in 100 pregnancies, is similar to that associated with paroxetine. Data are insufficient to draw conclusions about other SSRIs.

The possibility of cardiac defects in children exposed to fluoxetine in the womb should be weighed against the risks of untreated depression in pregnancy, which include low birth weight and preterm delivery. 

Further information: MHRA Drug Safety Update

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