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

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

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% [21–23]
Normal birth^a	401 (65.7%)	61% to 64% [24]
Premature^b	60 (9.8%)	12.8% [25]
Post-term^c	5 (0.8%)	5.6% [25]
Stillbirth	5 (0.8%)^h	0.5% to 1.1%ⁱ[26, 27]
Congenital anomaly^d	27 (4.4%)	3.0% to 5.0% [28, 29]
Perinatal condition^e	49 (8.0%)	^j
Post-perinatal condition^f	3 (0.5%)	^j

^a Includes neonates born at 37–42 weeks’ gestation, or at an unspecified gestation.
^b Includes neonates born <37 weeks’ gestation or reported as “premature.”
^c Includes neonates born >42 weeks or reported as “post-term.”
^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.
^e Includes neonates born at 37–42 weeks’ gestation or at an unspecified gestation with adverse event ≤7 days of birth.
^f Includes neonates born at 37–42 weeks’ gestation or at an unspecified gestation with an adverse event >7 days after birth.
^g Includes one report of a congenital anomaly in a 13-week aborted fetus.
^h Includes one report of a normal fetus who died when the mother committed suicide at 8 months’ gestation.
ⁱ Indicates range when stratified by race/ethnicity.
^j Due to the specific definitions (gestation and adverse events in a timeframe after birth), historical population rates are not available.
^† Clinical trial and spontaneous reports from the Lilly worldwide safety database (First human dose through 31 December 2010).

ISSN: 2050-6511