Signals of Adverse Drug Reactions of Paliperidone Compared to Other Atypical Antipsychotics Using the Korean Adverse Eve
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ORIGINAL RESEARCH ARTICLE
Signals of Adverse Drug Reactions of Paliperidone Compared to Other Atypical Antipsychotics Using the Korean Adverse Event Reporting System Database Dong‑Eun Seo1 · Seonji Kim2 · Byung‑Joo Park2
© Springer Nature Switzerland AG 2020
Abstract 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. Key Points A disproportionality analysis using the Korean Adverse Event Reporting System database showed meaningful signals after using paliperidone related to psychotic symptoms, metabolic problems, and endocrine disorders. These signals need further pharmacoepidemiological studies to confirm a causal association.
Dong-Eun Seo and Seonji Kim contributed equally to this work. * Byung‑Joo Park [email protected] 1
Seoul National University College of Medicine, Seoul, Republic of Korea
Department of Preventive Medicine, Seoul National University College of Medicine, 103 Daehak‑ro, Jongno‑gu, Seoul 03080, Republic of Korea
2
1 Introduction Schizophrenia is a severe public health problem and one of the top ten causes of disability around the world, affecting roughly 1.1% of the world’s population; the mean life expectancy of schizophrenia patients is 12–15 years lower than the general population in the USA [1]. Among South Korean adults, the lifetime prevalence rate of schizophrenia spectrum disorders was estimated to be 0.5% in 2016 and prevalent cases are increasing both
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