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Centre for Evidence-
Based Medicine

Pregnancy and SSRIs - Cannot rule out a significant increase in risk of major malformaion in fetus

Clinical Bottom Line

  1. It is impossible to exclude a significant risk. Until this gets sorted out properly, it would probably be prudent to avoid exposure to SSRIs unless absolutely necessary
  2. If this result is true, the NNH to cause one additional major malformation from exposure to an SSRI is 455

Citation

Kulin, NA. Pastuszak, A; Sage, AR et al Pregnancy outcome following maternal use of the new selective serotonin reuptake inhibitors: a prospective controlled multicenter study. JAMA 279 (8):609-610, 1998.

Clinical Question

In patients taking sertraline therapy what is the likelihood of an adverse outcome to pregancy?

Search Terms

PubMed using the filter for aetiology studies and selecting a sensitive search with the terms "selective serotonin reuptake inhibitors" and "pregnancy".

The Study

Prospective cohort of women attending Teratology Information Service centres in United States and Canada regarding exposure to fluvoxamine, paroxetine or sertraline during first trimester. Controls were women followed by the Motherisk Programme after exposure to agents proven to be non-teratogenic.

The Evidence

Major malformations Totals
Present (Case) Absent (Control)
Exposed to SSRI Yes (Cohort)

9

a

213

b

222

a + b

No (Cohort)

9

c

226

d

235

c + d

Totals

a + c

18

b + d

439

a + b + c + d

In this study:

Odds ratio (OR) = ad/bc
= 1.06 (95% Confidence interval 0.41 to 2.72)

Comments

  • Individuals on SSRIs had more parity, previous abortions and tobacco consumption than controls. No adjustment for these confounders was attempted but it is likely that any bias would increase the observed association.
  • The study included several SSRIs - fluvoxamine, paroxetine and does not examine them individually. We have to assume that they have similar effects. There are other studies investigating fluoxetine.
  • There are only 18 events in the whole cohort

Appraised By

Geddes 1999

Expiry Date

2000