ArticleRisk management and healthcare policy2020
Effects of a Safety Letter on Metoclopramide Use in Korea: An Interrupted Time-Series Analysis.
Article in Risk management and healthcare policy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
3 citing papers in PubMed.
- Antiemetic use during pregnancy and child neurodevelopment: population-based birth cohort study.BMC medicine · 2025Article
- Prevalence and causative drugs of drug-induced Parkinsonism in pediatric patients.European child & adolescent psychiatry · 2023Article
- Antiemetic treatment of hyperemesis gravidarum in 1,064 Norwegian women and the impact of European warning on metoclopramide: a retrospective cohort study 2002-2019.BMC pregnancy and childbirth · 2022Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Korean Ministry of Food and Drug Safety (MFDS) issued a safety letter regarding metoclopramide use and its adverse drug event of extrapyramidal disorder in October 2013. However, this safety letter had controversial effects on pharmacovigilance and management policies. The objective of this study was to estimate the impact of this government safety letter on the use of metoclopramide. PATIENTS AND
methodsWe conducted an interrupted time-series analysis using national claims data from January 2011 to December 2015 to assess the difference in metoclopramide utilization (ie, the total number of prescriptions per month, the average administration period per prescription per month, and the average dose per prescription per month) before and after the publication of the safety letter in October 2013.
resultsThe number of prescriptions, the average administration period per prescription, and the average dose per prescription of metoclopramide decreased after the publication of the safety letter. Notably, the decrease in the average administration period per prescription after the safety letter was statistically significant.
conclusionOur results indicate that the changes in the number of prescriptions, dose, and the duration of prescription may have occurred as a result of the restrictions and recommendations in the safety letter. Further research is needed to optimize the use of metoclopramide and to identify the risk of adverse drug events since the safety letter was issued.
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