Paroxetine and pregnancy
On this page, you will find information regarding the use of paroxetine during pregnancy – some of which relates to other antidepressants. In the US, paroxetine is pregnancy category D, which means that studies in pregnant women (controlled or observational) have demonstrated a risk to the human fetus, but the benefits of therapy may still outweigh the potential risks to the fetus. The information found below is provided to help prescribers and patients make informed treatment decisions.
Current Prescribing Information and Medical Information Letter (which reflect the findings below):
- US Prescribing Information
- Medical information letter (PDF)
- Use of Paxil CR tablets or Paxil tablets during pregnancy (PDF)
Paroxetine and Congenital Malformations. In 2005, GlaxoSmithKline sponsored a retrospective, U.S. epidemiologic study of major malformations following maternal exposure to antidepressants in the first trimester. This analysis showed a trend towards a 1.5-fold increased risk for cardiovascular malformations for paroxetine compared to other antidepressants. This study also showed a statistically significant increased overall risk of major congenital malformations (inclusive of the cardiovascular defects) in infants exposed to paroxetine compared to other antidepressants. A second, independent retrospective epidemiological analysis utilizing the Swedish national registry database reported a 2-fold increased risk of cardiac defects in infants exposed to paroxetine, compared with the general population. These two findings led GSK to revise its labeling by classifying paroxetine as a Pregnancy Category D product
- US: December 2005 communication and recommendations to Health Care Professionals. (PDF 73Kb)
- GSK-sponsored reports on bupropion and other antidepressants, including paroxetine, and specifically on paroxetine in pregnancy and the occurrence of cardiovascular and major congenital malformation have been posted to Clinical Study Register.
- Swedish national registry database study summary.
- FDA Advisory regarding category change.
- GSK conducted, in collaboration with the UNC-GSK Center of Excellence in Pharmacoepidemiology and Public Health, “Paroxetine Use in First Trimester of Pregnancy and the Prevalence of Congenital, Specifically Cardiac, Malformations: Systematic Review and Meta-Analysis of Epidemiological Data (updated 2009)”
Persistent Pulmonary Hypertension of the Newborn (PPHN) and SSRIs. In February 2006, a paper by Chambers and colleagues was published in the New England Journal of Medicine. This article reported that PPHN was seen in babies whose mothers received selective serotonin reuptake inhibitors (SSRIs), including paroxetine, after 20 weeks of pregnancy. In PPHN, the blood pressure is too high in the blood vessels between the baby's heart and the lungs, and, because of this, there is less oxygen in the bloodstream for use by the body. Based on this study, between 6 and 12 in 1000 babies whose mothers used SSRIs after 20 weeks of pregnancy would have this complication, compared with between 1 and 2 in 1000 babies in the general population. In April 2006, the FDA asked manufacturers of SSRIs to update their product labeling to reflect this findin
Discontinuation of Antidepressants during Pregnancy. In February 2006, a paper by Cohen and colleagues was published in the Journal of the American Medical Association which found that women with a history of depression who discontinued antidepressant medication relapsed (had symptoms of their depression return) significantly more frequently over the course of their pregnancy compared with women who maintained their medication. In April 2006, the FDA asked manufacturers of SSRIs to update their product labeling to reflect this finding