PMID- 32648200
OWN - NLM
STAT- MEDLINE
DCOM- 20201111
LR  - 20201111
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Linking)
VI  - 40
IP  - 9
DP  - 2020 Sep
TI  - Signals of Adverse Drug Reactions of Paliperidone Compared to Other Atypical 
      Antipsychotics Using the Korean Adverse Event Reporting System Database.
PG  - 873-881
LID - 10.1007/s40261-020-00945-z [doi]
AB  - BACKGROUND AND OBJECTIVES: Schizophrenia is a severe public health problem and 
      one of the top ten causes of disability, affecting about 1.1% of the world's 
      population. Paliperidone is a new atypical antipsychotic used to treat 
      schizophrenia. Several case reports about unexpected adverse drug reactions of 
      paliperidone have been consistently reported around the world. The purpose of 
      this study was to detect signals of adverse events (AEs) after paliperidone 
      treatment using the Korea Institute of Drug Safety and Risk Management-Korea 
      Adverse Event Reporting System database (KIDS-KD). METHODS: We applied 
      data-mining techniques based on a disproportionality analysis to KIDS-KD 
      consisting of spontaneously reported AE reports related to atypical 
      antipsychotics between January 2009 and December 2018. We calculated three 
      data-mining indices of paliperidone compared to all other atypical 
      antipsychotics. We defined signals that satisfied all three criteria of the 
      indices. We checked if the signals identified were included in the drug labels 
      for South Korea, the USA, the UK, Japan, Germany, and France. RESULTS: The total 
      number of suspected AE reports related to all atypical antipsychotics in the 
      KIDS-KD from January 2009 to December 2018 was 43,970. Among those, the number of 
      AE reports related to paliperidone was 9453. Overall, 13 signals such as 
      seborrhea, hallucination, obesity, gingivitis, and intervertebral disorder were 
      classified into newly detected meaningful signals. CONCLUSION: We detected new AE 
      signals of paliperidone that were not listed on the drug labels of six countries, 
      and many that were related to psychotic symptoms, metabolic problems, and 
      endocrine disorders.
FAU - Seo, Dong-Eun
AU  - Seo DE
AUID- ORCID: 0000-0003-3750-7529
AD  - Seoul National University College of Medicine, Seoul, Republic of Korea.
FAU - Kim, Seonji
AU  - Kim S
AUID- ORCID: 0000-0002-4993-7537
AD  - Department of Preventive Medicine, Seoul National University College of Medicine, 
      103 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.
FAU - Park, Byung-Joo
AU  - Park BJ
AUID- ORCID: 0000-0003-4630-4942
AD  - Department of Preventive Medicine, Seoul National University College of Medicine, 
      103 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea. bjpark@snu.ac.kr.
LA  - eng
PT  - Journal Article
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Antipsychotic Agents)
RN  - R8P8USM8FR (Paliperidone Palmitate)
SB  - IM
MH  - Algorithms
MH  - Antipsychotic Agents/*adverse effects
MH  - Data Mining
MH  - Databases, Factual
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - France
MH  - Germany
MH  - Humans
MH  - Japan
MH  - Paliperidone Palmitate/*adverse effects
MH  - Republic of Korea
MH  - Schizophrenia/*drug therapy
EDAT- 2020/07/11 06:00
MHDA- 2020/11/12 06:00
CRDT- 2020/07/11 06:00
PHST- 2020/07/11 06:00 [pubmed]
PHST- 2020/11/12 06:00 [medline]
PHST- 2020/07/11 06:00 [entrez]
AID - 10.1007/s40261-020-00945-z [pii]
AID - 10.1007/s40261-020-00945-z [doi]
PST - ppublish
SO  - Clin Drug Investig. 2020 Sep;40(9):873-881. doi: 10.1007/s40261-020-00945-z.