PMID- 32164630
OWN - NLM
STAT- MEDLINE
DCOM- 20201026
LR  - 20201026
IS  - 1471-244X (Electronic)
IS  - 1471-244X (Linking)
VI  - 20
IP  - 1
DP  - 2020 Mar 12
TI  - 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.
PG  - 118
LID - 10.1186/s12888-020-02525-z [doi]
LID - 118
AB  - BACKGROUND: Little is known regarding the association between adverse events 
      (AEs) and psychiatric medications administered to pregnant women in clinical 
      trials during the pre-marketing period. This study analyzes reports of AE 
      association with psychiatric medication administrated during pregnancy using 
      post-marketing spontaneous reports of AE from the Japanese Adverse Drug Event 
      Report (JADER) database and Food and Drug Administration Adverse Event Reporting 
      System in the United States (FAERS-US). METHODS: We summarized AE reports of 
      psychiatric medication administrated during pregnancy by comparing data obtained 
      from JADER and FAERS-US databases with medication patterns determined as classes 
      via latent class analysis. The odds ratios (ORs) of AE reports categorized into 
      system organ classes in which each class was compared with those without 
      psychiatric medications. RESULTS: The proportions of AE reports under psychiatric 
      medication in pregnancy among all AE reports were 22.0% and 16.6% in JADER and 
      FAERS-US, respectively. The 10,389 reports of psychiatric medication during 
      pregnancy were classified into 11 classes. The proportion of patients receiving 
      four or more psychiatric drugs in JADER was larger than that in FAERS-US. The 
      maximum number of reports in combinations of AE and medication pattern in JADER 
      was 169, for 'general disorders and administration site conditions' from the 
      class of four or more medications (OR = 9.1), while that in FAERS-US was 1,654, 
      for 'injury, poisoning, and procedural complications' from the class of single 
      psychiatric medication (OR = 2.8). CONCLUSIONS: The main AE reports and 
      associated AE differed depending on medication patterns in pregnant women taking 
      psychiatric medication. This study may provide a prediction of AEs that are 
      likely to be reported with each medication pattern. Our findings of the 
      association between AE reports and medication patterns could help improve the 
      administration of psychiatric medications during pregnancy, though further 
      research on additional datasets is needed to clarify these results.
FAU - Anzai, Tatsuhiko
AU  - Anzai T
AD  - Keio University Graduate School of Health Management, 4411 Endo, Fujisawa-shi, 
      Kanagawa, 252-0883, Japan. tanzai04@keio.jp.
AD  - Statistics Analysis Department 1, EPS Corporation, 6-85 Shinogawa-machi, 
      Shinjuku-ku, Tokyo, 162-0815, Japan. tanzai04@keio.jp.
FAU - Takahashi, Kunihiko
AU  - Takahashi K
AD  - Department of Biostatistics, Nagoya University Graduate School of Medicine, 65 
      Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
FAU - Watanabe, Michiko
AU  - Watanabe M
AD  - Keio University Graduate School of Health Management, 4411 Endo, Fujisawa-shi, 
      Kanagawa, 252-0883, Japan.
FAU - Mochizuki, Mayumi
AU  - Mochizuki M
AD  - Keio University Faculty of Pharmacy, 1-5-30 Shibakoen, Minato-ku, Tokyo, 
      105-8512, Japan.
FAU - Murashima, Atsuko
AU  - Murashima A
AD  - Japan Drug Information Institute in Pregnancy (J-TIS), National Center for Child 
      Health and Development, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan.
LA  - eng
GR  - JP18mk0101086./Japan Agency for Medical Research and Development/International
GR  - JP18mk0101086./Japan Agency for Medical Research and Development/International
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200312
PL  - England
TA  - BMC Psychiatry
JT  - BMC psychiatry
JID - 100968559
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Humans
MH  - Japan
MH  - *Latent Class Analysis
MH  - Mental Disorders/*drug therapy
MH  - Middle Aged
MH  - Pregnancy
MH  - Pregnancy Complications/*drug therapy/*psychology
MH  - United States
MH  - United States Food and Drug Administration
MH  - Young Adult
PMC - PMC7068895
OTO - NOTNLM
OT  - adverse events
OT  - latent class analysis
OT  - polypharmacy
OT  - pregnancy
OT  - psychiatric medication
OT  - spontaneous reports
COIS- T.A. is an employee of EPS Corporation. A.M. received honoraria from Astellas 
      Pharma Co. Ltd., Chugai Pharmaceutical Co. Ltd. and Mitsubishi Tanabe Pharma Co. 
      Ltd. All other authors have no conflicts of interest directly relevant to the 
      content of this study.
EDAT- 2020/03/14 06:00
MHDA- 2020/10/27 06:00
PMCR- 2020/03/12
CRDT- 2020/03/14 06:00
PHST- 2019/08/10 00:00 [received]
PHST- 2020/03/03 00:00 [accepted]
PHST- 2020/03/14 06:00 [entrez]
PHST- 2020/03/14 06:00 [pubmed]
PHST- 2020/10/27 06:00 [medline]
PHST- 2020/03/12 00:00 [pmc-release]
AID - 10.1186/s12888-020-02525-z [pii]
AID - 2525 [pii]
AID - 10.1186/s12888-020-02525-z [doi]
PST - epublish
SO  - BMC Psychiatry. 2020 Mar 12;20(1):118. doi: 10.1186/s12888-020-02525-z.