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

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

	Outcomes reported by trimester(s) of exposure to Olanzapine (n)
Pregnancy outcome	1^stonly	2^ndonly	3^rdonly	1^st& 2^nd	1 & 3^rd	2^nd& 3^rd	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

^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 an adverse event ≤7 days after 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 normal fetus who died when the mother committed suicide at 8 months’ gestation.
^† First Human Dose through 31 December 2010 (Data on file).

ISSN: 2050-6511