Paroxetine exposure during pregnancy and cardiac malformations

Selective serotonin reuptake inhibitor antidepressant use in first trimester pregnancy and risk of specific congenital anomalies: a European register-based study

“…We found a statistically significant association between SSRIs as a class and CHD overall supporting previous reports of this association [22-37, 46-47, 68]. We have been able to show in addition that the association is stronger for severe CHD and, therefore, is unlikely to be explained as neonatal examination bias or more frequent echocardiograms or other screening/diagnostic procedures for SSRI exposed infants [48,[57][58]. We have also shown that the association is not specific to any one SSRI type, although the power of the study to estimate differences between the effects associated with specific SSRIs was limited.…”

“…It has been suggested that the apparent excess risk of less severe CHDs might reflect ascertainment bias due to greater likelihood of exposed babies receiving special neonatal care [48,[57][58]. Other studies have focused on confounding by indication or co-exposures including co-medications [23,33,59] finding evidence of attenuation of CHD risk.…”

Fibromyalgia

“…Paroxetine, a selective serotonin reuptake inhibitor (SSRI), highlights the saga that a drug may take from initial approval to heightened awareness of possible harm. Data from a large US insurance company UnitedHealthcare persuaded the US Food and Drug Administration to issue paroxetine a Category D status due to elevated risk of cardiovascular malformations, such as ventricular and atrial septal defects [64,233]. Swedish researchers found that the use of paroxetine in early pregnancy had an odds ratio of 1.09 for cardiac malformations, although the 95 % confidence interval ranged from 0.62 to 1.92 [120].…”

“…Many studies drawing such associations have been criticized for insufficient power, poor ascertainment of birth defects, and other methodological limitations [8]. Even those authors of studies finding statistically significant associations note the relatively low rate of malformation occurrence, large range of confidence intervals, and odds ratios that are at best modestly elevated from unity [233]. When drawing conclusions from future studies, looking at those studies with objective measurements, prospective sampling, and clinical significance will provide more robust clinical information [34].…”

Selective Serotonin Reuptake Inhibitors in Human Pregnancy: To Treat or Not to Treat?

“…In the meta-analysis published by Wurst et al [44], there was an increased risk for combined cardiac defects and aggregated congenital defects with first trimester paroxetine use. Two opposing commentaries on this topic were recently published [45, 46]. The definition of cardiovascular malformations varied among studies, some including small septal defects, while others excluded them.…”