Adverse event reports in patients taking psychiatric medication during pregnancy from spontaneous reports in Japan and the United States: an approach using latent class analysis

Anzai, Tatsuhiko; Takahashi, Kunihiko; Watanabe, Michiko; Mochizuki, Mayumi; Murashima, Atsuko

doi:10.1186/s12888-020-02525-z

Table 4 OR of reporting AEs by medication class of pregnancy in FAERS-US, categorized based on system organ class (SOC)

From: Adverse event reports in patients taking psychiatric medication during pregnancy from spontaneous reports in Japan and the United States: an approach using latent class analysis

	Class 1 n=2,079	Class 2 n=1,734	Class 3 n=1,297	Class 4 n=571	Class 5 n=1,080	Class 6 n=364	Class 7 n=438	Class 8 n=364	Class 9 n=367	Class 10 n=268	Class 11 n=173	Reports in pregnancy without psychiatric medications, n=43,807
SOC	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	n (reference)
Preg	447	615	549	214	98	189	139	147	145	53	103	20,376
Preg	0.3 (0.3,0.4)	0.6 (0.6,0.7)	0.8 (0.8,0.9)	0.7 (0.6,0.8)	0.1 (<0.1,0.1)	1.2 (1.0,1.5)	0.5 (0.4,0.7)	0.8 (0.6,1.0)	0.8 (0.6,0.9)	0.3 (0.2,0.4)	1.7 (1.2,2.3)	1.0
Cong	711	629	319	210	931	88	65	33	156	35	29	7,337
Cong	2.6 (2.4,2.8)	2.8 (2.6,3.1)	1.6 (1.4,1.8)	2.9 (2.4,3.4)	31.1 (26.1,37.0)	1.6 (1.2,2.0)	0.9 (0.7,1.1)	0.5 (0.3,0.7)	3.7 (3.0,4.5)	0.7 (0.5,1.1)	1.0 (0.7,1.5)	1.0
Resp	61	283	130	117	97	3	47	9	43	23	23	3,192
Resp	0.4 (0.3,0.5)	2.5 (2.2,2.8)	1.4 (1.2,1.7)	3.3 (2.7,4.0)	1.3 (1.0,1.6)	-	1.5 (1.1,2.1)	0.3 (0.2,0.6)	1.7 (1.2,2.3)	1.2 (0.8,1.8)	2.0 (1.3,3.0)	1.0
Genrl	328	549	304	165	103	59	123	42	97	174	44	12,315
Genrl	0.5 (0.4,0.5)	1.2 (1.1,1.3)	0.8 (0.7,0.9)	1.0 (0.9,1.2)	0.3 (0.2,0.3)	0.5 (0.4,0.7)	1.0 (0.8,1.2)	0.3 (0.2,0.5)	0.9 (0.7,1.2)	4.7 (3.7,6.1)	0.9 (0.6,1.2)	1.0
Nerv	459	379	219	129	110	89	215	24	44	44	33	3,394
Nerv	3.4 (3.0,3.8)	3.3 (3.0,3.8)	2.4 (2.1,2.8)	3.5 (2.8,4.2)	1.4 (1.1,1.7)	3.9 (3.0,4.9)	11.5 (9.5,13.9)	0.8 (0.6,1.3)	1.6 (1.2,2.2)	2.3 (1.7,3.2)	2.8 (1.9,4.1)	1.0
Psych	253	344	250	122	108	31	81	40	46	36	46	3,251
Psych	1.7 (1.5,2.0)	3.1 (2.7,3.5)	3.0 (2.6,3.4)	3.4 (2.8,4.2)	1.4 (1.1,1.7)	1.2 (0.8,1.7)	2.8 (2.2,3.6)	1.5 (1.1,2.1)	1.8 (1.3,2.4)	1.9 (1.4,2.8)	4.5 (3.2,6.3)	1.0
Inv	95	277	143	101	130	24	33	16	33	17	32	3,502
Inv	0.6 (0.4,0.7)	2.2 (1.9,2.5)	1.4 (1.2,1.7)	2.5 (2.0,3.1)	1.6 (1.3,1.9)	0.8 (0.5,1.2)	0.9 (0.7,1.3)	0.5 (0.3,0.9)	1.1 (0.8,1.6)	0.8 (0.5,1.3)	2.6 (1.8,3.8)	1.0
Metab	73	177	76	62	30	6	38	5	21	10	42	1,878
Metab	0.8 (0.6,1.0)	2.5 (2.2,3.0)	1.4 (1.1,1.8)	2.7 (2.1,3.6)	0.6 (0.4,0.9)	0.4 (0.2,0.8)	2.1 (1.5,3.0)	-	1.4 (0.9,2.1)	0.9 (0.5,1.6)	7.2 (5.0,10.2)	1.0
Inj&P	1654	1170	1034	423	1064	269	251	324	296	196	136	25,556
Inj&P	2.8 (2.5,3.1)	1.5 (1.3,1.6)	2.8 (2.4,3.2)	2.0 (1.7,2.5)	47.3 (28.9,77.4)	2.0 (1.6,2.6)	1.0 (0.8,1.2)	5.8 (4.2,8.0)	3.0 (2.3,3.9)	1.9 (1.5,2.5)	2.6 (1.8,3.8)	1.0
Card	66	179	86	89	153	8	21	2	55	30	13	1,770
Card	0.8 (0.6,1.0)	2.7 (2.3,3.2)	1.7 (1.3,2.1)	4.4 (3.5,5.5)	3.9 (3.3,4.7)	0.5 (0.3,1.1)	1.2 (0.8,1.9)	-	4.2 (3.1,5.6)	3.0 (2.0,4.4)	1.9 (1.1,3.4)	1.0
Musc	43	226	79	73	52	12	19	2	34	25	8	2,430
Musc	0.4 (0.3,0.5)	2.6 (2.2,3.0)	1.1 (0.9,1.4)	2.5 (1.9,3.2)	0.9 (0.6,1.1)	0.6 (0.3,1.0)	0.8 (0.5,1.2)	-	1.7 (1.2,2.5)	1.8 (1.2,2.6)	0.8 (0.4,1.7)	1.0
Gastr	145	350	153	91	56	19	73	3	33	39	33	4,137
Gastr	0.7 (0.6,0.9)	2.4 (2.1,2.7)	1.3 (1.1,1.5)	1.8 (1.4,2.3)	0.5 (0.4,0.7)	0.5 (0.3,0.8)	1.9 (1.5,2.5)	-	0.9 (0.7,1.4)	1.6 (1.2,2.3)	2.3 (1.5,3.3)	1.0
Surg	36	112	83	39	10	10	15	27	14	13	37	2,348
Surg	0.3 (0.2,0.4)	1.2 (1.0,1.5)	1.2 (1.0,1.5)	1.3 (0.9,1.8)	0.2 (<0.1,0.3)	0.5 (0.3,0.9)	0.6 (0.4,1.0)	1.4 (1.0,2.1)	0.7 (0.4,1.2)	0.9 (0.5,1.6)	4.8 (3.3,6.9)	1.0
Blood	4	144	31	34	5	2	10	0	11	9	2	1,458
Blood	-	2.6 (2.2,3.1)	0.7 (0.5,1.0)	1.8 (1.3,2.6)	-	-	0.7 (0.4,1.3)	-	0.9 (0.5,1.6)	1.0 (0.5,2.0)	-	1.0
Skin	23	126	46	29	9	2	15	1	16	6	0	2,015
Skin	0.2 (0.2,0.4)	1.6 (1.3,2.0)	0.8 (0.6,1.0)	1.1 (0.8,1.6)	0.2 (<0.1,0.3)	-	0.7 (0.4,1.2)	-	0.9 (0.6,1.6)	0.5 (0.2,1.1)	-	1.0
Hepat	11	49	26	22	21	2	3	1	7	2	15	657
Hepat	0.3 (0.2,0.6)	1.9 (1.4,2.6)	1.3 (0.9,2.0)	2.6 (1.7,4.1)	1.3 (0.8,2.0)	-	-	-	1.3 (0.6,2.7)	-	6.2 (3.7,10.6)	1.0
Infec	38	264	79	68	60	8	33	8	79	5	15	3,181
Infec	0.2 (0.2,0.3)	2.3 (2.0,2.6)	0.8 (0.7,1.0)	1.7 (1.3,2.2)	0.8 (0.6,1.0)	0.3 (0.1,0.6)	1.0 (0.7,1.5)	0.3 (0.1,0.6)	3.5 (2.7,4.5)	-	1.2 (0.7,2.1)	1.0
Immun	3	48	11	13	3	2	2	1	23	0	0	550
Immun	-	2.2 (1.7,3.0)	0.7 (0.4,1.2)	1.8 (1.1,3.2)	-	-	-	-	5.3 (3.4,8.1)	-	-	1.0
Eye	31	60	32	24	24	4	11	2	8	18	4	725
Eye	0.9 (0.6,1.3)	2.1 (1.6,2.8)	1.5 (1.1,2.2)	2.6 (1.7,3.9)	1.4 (0.9,2.0)	-	1.5 (0.8,2.8)	-	1.3 (0.7,2.7)	4.3 (2.6,6.9)	-	1.0
Repro	46	131	88	36	13	7	10	10	24	5	6	2,944
Repro	0.3 (0.2,0.4)	1.1 (0.9,1.4)	1.0 (0.8,1.3)	0.9 (0.7,1.3)	0.2 (<0.1,0.3)	0.3 (0.1,0.6)	0.3 (0.2,0.6)	0.4 (0.2,0.7)	1.0 (0.6,1.5)	-	0.5 (0.2,1.1)	1.0
Vasc	24	144	61	55	30	5	14	1	22	8	4	1,675
Vasc	0.3 (0.2,0.4)	2.3 (1.9,2.7)	1.2 (1.0,1.6)	2.7 (2.0,3.6)	0.7 (0.5,1.0)	-	0.8 (0.5,1.4)	-	1.6 (1.0,2.5)	0.8 (0.4,1.6)	-	1.0
Neopl	8	60	20	12	10	2	7	0	4	3	2	668
Neopl	0.2 (0.1,0.5)	2.3 (1.8,3.0)	1.0 (0.6,1.6)	1.4 (0.8,2.5)	0.6 (0.3,1.1)	-	1.1 (0.5,2.2)	-	-	-	-	1.0
Endo	18	40	9	9	3	0	1	0	3	0	3	339
Endo	1.1 (0.7,1.8)	3.0 (2.2,4.2)	0.9 (0.5,1.7)	2.1 (1.1,4.0)	-	-	-	-	-	-	-	1.0
Ear	17	44	14	11	18	2	4	1	10	1	1	422
Ear	0.8 (0.5,1.4)	2.7 (2.0,3.7)	1.1 (0.7,1.9)	2.0 (1.1,3.7)	1.7 (1.1,2.8)	-	-	-	2.9 (1.5,5.4)	-	-	1.0
Renal	10	99	33	28	32	4	6	3	11	4	5	1,037
Renal	0.2 (0.1,0.4)	2.5 (2.0,3.1)	1.1 (0.8,1.5)	2.1 (1.4,3.1)	1.3 (0.9,1.8)	-	0.6 (0.3,1.3)	-	1.3 (0.7,2.3)	-	-	1.0
SocCi	124	50	38	8	4	13	10	37	6	4	8	517
SocCi	5.3 (4.3,6.5)	2.5 (1.9,3.3)	2.5 (1.8,3.5)	1.2 (0.6,2.4)	-	3.1 (1.8,5.4)	2.0 (1.0,3.7)	9.5 (6.7,13.5)	1.4 (0.6,3.1)	-	4.1 (2.0,8.3)	1.0
Prod	11	59	38	15	2	2	7	0	12	1	1	1,627
Prod	0.1 (<0.1,0.3)	0.9 (0.7,1.2)	0.8 (0.6,1.1)	0.7 (0.4,1.2)	-	-	0.4 (0.2,0.9)	-	0.9 (0.5,1.6)	-	-	1.0

Significant results with p<0.05 in boldface
OR was estimated in cells with > 5 events
AE Adverse event, OR Odds ratio, SOC System organ class, Blood Blood and lymphatic system disorders, Card Cardiac disorders, Cong Congenital, familial and genetic disorders, Ear Ear and labyrinth disorders, Endo Endocrine disorders, Eye Eye disorders, Gastr Gastrointestinal disorders, Genrl General disorders and administration site conditions, Hepat Hepatobiliary disorders, Immun Immune system disorders, Infec Infections and infestations, Inj&P Injury, poisoning and procedural complications, Inv Investigations, Metab Metabolism and nutrition disorders, Musc Musculoskeletal and connective tissue disorders, Neopl Neoplasms benign, malignant and unspecified (incl cysts and polyps), Nerv Nervous system disorders, Preg Pregnancy, puerperium and perinatal conditions, Prod Product issues, Psych Psychiatric disorders, Renal Renal and urinary disorders, Repro Reproductive system and breast disorders, Resp Respiratory, thoracic and mediastinal disorders, Skin Skin and subcutaneous tissue disorders, SocCi Social circumstances, Surg Surgical and medical procedures, Vasc Vascular disorders

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