in Padua, Italy, or the Pharmakovigilanz-und Beratungszentrum fur Embryonaltoxikologie in Berlin, Germany.
All three belong to the European Network of Teratology Information Services, which comprises organisations that investigate, and provide counselling on, environmental exposure during pregnancy.
The women in the control group had contacted the services because of concerns about exposure to substances that are not known to cause birth defects and the women in the medication groups because of their use of paroxetine and fluoxetine.
When the researchers looked at the outcomes of all of the pregnancies they found that:
- The prevalence of major heart anomalies was 2.8% in the fluoxetine group, 2% in the paroxetine group and 0.6% in the control group. There was no increase in other major congenital anomalies.
- Previous pregnancy terminations were also higher in the fluoxetine and paroxetine groups than the control group (7.8%, 4.8% and 2.8%). All groups included some terminations because of diagnosed anomalies.
- Birth weights were slightly lower in the fluoxetine and paroxetine groups than the control group (3200g, 3250g and 3300g).
- Women taking fluoxetine and paroxetine were more likely to smoke than women in the control group (20.1%, 20.7% and 7.5%) and more likely to smoke more than ten cigarettes a day (12.3%, 14% and 4.4%).
Taking all the factors into account, the authors calculated that the overall risk posed by antidepressant use and cigarette consumption was as follows:
- Women who took fluoxetine during pregnancy were 4.47 times more likely to have a baby with a heart anomaly and women who took paroxetine were 2.66 times more likely.
- Those smoking more than ten cigarettes a day were 5.40 times more likely to have a baby with a heart anomaly and women smoking less than ten cigarettes a day were 2.75 times more likely.
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