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Table 2 Trimester of olanzapine exposure in prospectively identified pregnancies by outcome from Lilly Worldwide Safety Database

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

  Outcomes reported by trimester(s) of exposure to Olanzapine (n)
Pregnancy outcome 1stonly 2ndonly 3rdonly 1st& 2nd 1 & 3rd 2nd& 3rd All Unknown Total
Normal birth a 109 14 18 37 7 21 189 6 401
  Full-term 96 12 17 33 6 20 169 4 357
  Unknown gestation 13 2 1 4 1 1 20 2 44
Spontaneous abortion a 50 1 0 4 0 0 0 2 57 g
Ectopic pregnancy 3 0 0 0 0 0 0 0 3
Premature b 11 1 2 4 1 11 27 3 60
  Normal 7 1 0 3 1 8 18 3 41
  Congenital anomaly 2 0 0 0 0 0 2 0 4
  Perinatal condition 2 0 2 1 0 3 7 0 15
Post-term c 0 0 2 0 0 0 3 0 5
  Normal 0 0 2 0 0 0 1 0 3
  Perinatal condition 0 0 0 0 0 0 2 0 2
Stillbirth 0 0 0 0 0 1 4 0 5 h
Congenital anomaly d 3 1 2 4 0 7 8 2 27
  Full-term 2 1 2 1 0 4 8 0 18
  Unknown gestation 0 0 0 2 0 3 0 2 7
  Therapeutic abortion 1 0 0 1 0 0 0 0 2
Perinatal condition e 9 0 3 2 0 1 31 3 49
  Full-term 8 0 3 1 0 1 28 3 44
  Unknown gestation 1 0 0 1 0 0 3 0 5
Post-perinatal condition f 2 0 0 0 0 0 1 0 3
  Full-term 2 0 0 0 0 0 1 0 3
Totals 187 17 27 51 8 41 263 16 610
  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 an adverse event ≤7 days after 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 normal fetus who died when the mother committed suicide at 8 months’ gestation.
  9. First Human Dose through 31 December 2010 (Data on file).