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Table 1 Fetal outcomes in prospectively identified olanzapine-exposed pregnancies, compared to rates in the general population

From: Olanzapine in pregnancy and breastfeeding: a review of data from global safety surveillance

Fetal outcome Outcome reported (%) (N=610) Historic control rate in general population (%)
Spontaneous abortion 57 (9.3%)g 10% to 20% [19, 20]
Ectopic pregnancy 3 (0.5%) 1.3% to 2.1% [2123]
Normal birtha 401 (65.7%) 61% to 64% [24]
Prematureb 60 (9.8%) 12.8% [25]
Post-termc 5 (0.8%) 5.6% [25]
Stillbirth 5 (0.8%)h 0.5% to 1.1%i[26, 27]
Congenital anomalyd 27 (4.4%) 3.0% to 5.0% [28, 29]
Perinatal conditione 49 (8.0%) j
Post-perinatal conditionf 3 (0.5%) j
  1. a Includes neonates born at 37–42 weeks’ gestation, or at an unspecified gestation.
  2. b Includes neonates born <37 weeks’ gestation or reported as “premature.”
  3. c Includes neonates born >42 weeks or reported as “post-term.”
  4. d Includes neonates born at 37–42 weeks’ gestation or at an unspecified gestation with a congenital abnormality (resulting from abnormal tissue formation) at birth, and reports of therapeutic abortions due to congenital abnormalities in the fetus.
  5. e Includes neonates born at 37–42 weeks’ gestation or at an unspecified gestation with adverse event ≤7 days of birth.
  6. f Includes neonates born at 37–42 weeks’ gestation or at an unspecified gestation with an adverse event >7 days after birth.
  7. g Includes one report of a congenital anomaly in a 13-week aborted fetus.
  8. h Includes one report of a normal fetus who died when the mother committed suicide at 8 months’ gestation.
  9. i Indicates range when stratified by race/ethnicity.
  10. j Due to the specific definitions (gestation and adverse events in a timeframe after birth), historical population rates are not available.
  11. Clinical trial and spontaneous reports from the Lilly worldwide safety database (First human dose through 31 December 2010).