Using paroxetine- a medication prescribed to treat conditions including depression, obsessive-compulsive disorder, anxiety and posttraumatic stress disorder- during the first trimester of pregnancy may increase the newborns' risk of congenital malformations and cardiac malformations.
Up to one-fifth of women of childbearing age experience depressive symptoms that often lead to mild to moderate depression, and prescriptions for antidepressants during pregnancy have increased in recent years.
A small unpublished study conducted by the manufacturer, however, suggested an increased risk of cardiac malformations in infants exposed to paroxetine before birth.
Subsequent studies using various study designs in different populations across Europe and North America generated conflicting results in terms of statistical significance, although a trend remained towards an increased risk.
To provide a comprehensive assessment of the effects of paroxetine on newborns, a team led by Professor Anick Berard conducted a literature review and meta-analysis of all relevant studies published from 1966 to 2015.
Compared with no use of paroxetine, first trimester use of paroxetine was associated with a 23 percent increased risk of any major congenital malformations and a 28 percent increased risk of major cardiac-malformations in newborns.