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Regulator warns on congential heart defects with SSRI

By Nigel Praities

The UK medicines regulator has warned of a ‘possible small risk' of congenital heart defects when prescribing the selective-serotonin reuptake inhibitor fluoxetine.

The Medicines and Healthcare products Regulatory Agency said they had looked at the evidence from a number of studies and had calculated that fluoxetine doubles the background rate of congenital heart defects.

The background incidence of congenital cardiac defects is approximately 1/100 and the MHRA estimates to increase to less than 2/100 pregnancies with fluoxetine prescription.

The MHRA said that a class effect with SSRIs on heart formation in utero ‘could not be excluded' and recommended GPs were mindful of this when prescribing the drugs.

A MHRA statement said: ‘When prescribing fluoxetine to treat depression during pregnancy, prescribers should be aware that there may be a small increased risk of congenital cardiac defects in infants exposed in early pregnancy, similar to that seen with paroxetine.'

Drug Safety Update; 3(8); pg. 4

Regulator warns 'small risk' of congential heart defects with fluoxetine MHRA advice

• When prescribing fluoxetine to treat depression during pregnancy, prescribers should be aware that there may be a small increased risk of congenital cardiac defects in infants exposed in early pregnancy, similar
to that seen with paroxetine

• There are insufficient data to draw conclusions on the risk of congenital anomalies with other SSRIs, but the possibility of a class effect cannot be excluded

• The potential increased risk should be considered in the context of the benefits of treating depression in pregnancy

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