CRITICAL APPRAISAL OF SYSTEMATIC REVIEWS ASSESSING SAFETY OUTCOMES OF SSRIS IN THE PERINATAL PERIOD

Author(s)

Merlo GB, Elliot L, Campbell S, Norris SHealth Technology Analysts Pty Ltd, Sydney, NSW, Australia

OBJECTIVES: A systematic appraisal was conducted of published systematic reviews that assessed the harms associated with selective serotonergic reuptake inhibitors (SSRIs) in the perinatal period, both for the mother and infant.  METHODS: A systematic method of literature searching and selection was employed for this review. Searches were conducted in EMBASE, Medline and the Cochrane Database of Systematic Reviews. Studies were eligible if they evaluated pregnancy or infant-related safety outcomes for SSRI use in pregnant or lactating women.  RESULTS: The literature search identified seventeen systematic reviews and three subsequently published prospective cohort studies. None of the systematic reviews assessing serotonergic antidepressants as a group found an association with congenital malformations. An association between paroxetine exposure and infant cardiovascular malformations has been reported in the literature; however, more recent evidence from a large systematic review shows no relationship between paroxetine exposure and congenital cardiac malformations. Neonatal symptoms (such as withdrawal symptoms, lower Apgar score, and diminished response to pain stimulus) have been reported in 20-30% of infants with third trimester SSRI exposure. All of the reviews reported the symptoms as mild and self-limiting. Several SRs found a significant association between SSRI use in pregnancy and premature delivery, low birth-weight, and admission to special care nurseries. There is conflicting evidence regarding the long-term neurodevelopmental risks of serotonergic antidepressants. Although the levels of SSRIs in breast milk are relatively low, the evidence for the safety of antidepressant exposure via breastfeeding is limited.   CONCLUSIONS: SSRI exposure during pregnancy is associated with mostly minor and temporary adverse outcomes for the newborn. The risk of these outcomes needs to be balanced with the risk of adverse outcomes resulting from SSRI withdrawal for the mother.

Conference/Value in Health Info

2010-09, ISPOR Asia Pacific 2010, Phuket, Thailand

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PIH1

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Mental Health, Pediatrics, Reproductive and Sexual Health

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