Paroxetine (Paxil/Seroxat) linked with increased risk of birth defects when taken in early pregnancy


Using paroxetine – a drug prescribed to treat conditions including depression, obsessive-compulsive disorder, anxiety and posttraumatic stress disorder – during the first trimester of pregnancy may increase newborns’ risk of congenital malformations and cardiac malformations.

That’s the conclusion of a recent analysis published in the British Journal of Clinical Pharmacology. Paroxetine is the active ingredient of GlaxoSmithKline’s once blockbuster but now off-patent Paxil/Seroxat.

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. The most common drugs for treating depression in pregnant women are selective serotonin reuptake inhibitors, and up until 2005, one drug in that class – paroxetine – was considered to be safe for use during pregnancy. A small unpublished study conducted by the manufacturer, however, suggested an increased risk of cardiac malformations in infants exposed to paroxetine before birth.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 Bérard of CHU Sainte-Justine and the University of Montreal, conducted a literature review and meta-analysis of all relevant studies published from 1966 to 2015. The investigators uncovered 23 eligible studies.

Results of meta-analysis

Compared with no use of paroxetine, first trimester use of paroxetine was associated with a 23% increased risk of any major congenital malformations and a 28% increased risk of major cardiac malformations in newborns. The investigators noted that the baseline risk of major malformations is 3% and of cardiac malformations is 1%; however, any increase in risk is significant, especially when considering that the benefit of using selective serotonin reuptake inhibitors during pregnancy – when changes in metabolism cause the drugs to be cleared from the body at a faster rate -is debatable.

“Given that the benefits of antidepressants overall, and selective serotonin reuptake inhibitors including paroxetine specifically, during pregnancy is questionable at best, any increase in risk – small or large – is too high,” said Prof Bérard, adding: “Indeed, the risk/benefit ratio suggests non-use in women with mild to moderately depressive symptoms, which is 85% of pregnant women with depressive symptoms. Therefore, planning of pregnancy is essential, and valid treatment options such as psychotherapy or exercise regimens are warranted in this special population.”

Paroxetne, Birth defects, Risk, Pregnancy, Meta-analysis, British Journal of Clinical Pharmacology



  1. kiwi

    Question: Just what exactly is needed before a medicine or should i say poison is pulled from the market?
    Lets see we have drug induced suicides by the thousands, and you can bet suicide attempts in excess of this, drug induced suicidal thoughts in excess of this which in my case i had to battle daily for several years while i endured withdrawal completely unacknowledged by the ex doc, malformations in the unborn, sexual ruination in adults, levels of dependancy established that take drug addiction to a whole new galaxy, possible brain and neurological damage resulting in loss of motivation, apathy syndrome, cognitive impairment memory loss, anhedonia, corkscrewing of serotonergic neurons. I could go on.
    Evidence of pharma fraud and nefarious behavior that triggers a deafening silent ‘no comment’ from the perpetrators of this crime.
    How much more incriminating evidence do they need before action is taken?
    Surely enough is enough.

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