&lt;p&gt;Effects of a Safety Letter on Metoclopramide Use in Korea: An Interrupted Time-Series Analysis&lt;/p&gt;

Kim, Hyungtae; Suh, Hae Sun

doi:10.2147/rmhp.s263579

Cited by 3 publications

(1 citation statement)

References 27 publications

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“…Interrupted time-series analyses are considered suitable for investigating changes in aggregated data in a population following a point of intervention [ 23 ], and has been used to investigate the effect of policy changes on metoclopramide prescriptions in Korea and the US [ 32 , 33 ]. However, the ITSA-model assumes a change at the time of intervention and estimates the effects based on this assumption.…”

Section: Discussionmentioning

confidence: 99%

Antiemetic treatment of hyperemesis gravidarum in 1,064 Norwegian women and the impact of European warning on metoclopramide: a retrospective cohort study 2002–2019

Erdal

Holst

Heitmann

et al. 2022

BMC Pregnancy Childbirth

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Background Women suffering from severe nausea and vomiting during pregnancy, hyperemesis gravidarum, have poor quality of life and increased risk of potentially fatal maternal and fetal complications. There is increasing and reassuring knowledge about safety of antiemetics in pregnancy. In 2013, the European Medical Agency (EMA) issued a warning on metoclopramide limiting treatment to maximum five days. Metoclopramide was the most used antiemetic in pregnancy at the time the warning was implemented in the Norwegian hyperemesis guidelines (2014). We aimed at describing changes in the treatment of hyperemesis over time, including changes associated with the EMA warning. Methods Retrospective chart review of all women hospitalized for hyperemesis gravidarum with metabolic disturbances between 01/Jan/2002 and 31/Dec/2019 at a university hospital serving nearly 10% of the pregnant population in Norway. Time-series analysis described changes over time and interrupted time series analysis quantified changes in treatment and clinical outcomes related to the EMA warning. Results In total, 1,064 women (1.2% of the birthing population) were included. The use of meclizine, prochlorperazine, and ondansetron increased during 2002–2019. This led to a yearly increase in the percentage of women using any antiemetic of 1.5% (95%CI 0.6; 2.4) pre-hospital, 0.6% (95%CI 0.2; 1.1) during hospitalization, and 2.6% (95%CI 1.3; 3.8) at discharge. Overall, only 50% of the women received antiemetics pre-hospital. Following the EMA warning, prehospital use of metoclopramide dropped by 30% (95%CI 25; 36), while use of any antiemetic pre-hospital dropped by 20% (95%CI 5.7; 34). In timely association, we observed a decrease in gestational age (-3.8 days, 98.75%CI 0.6; 7.1) at first admission, as well as indication of increased rate of termination of pregnancy with an absolute increase of 4.8% (98.75%CI 0.9; 8.7) in 2014. Conclusion During 2002–2019, the overall use of antiemetics in treatment of hyperemesis increased. The EMA-warning on metoclopramide in 2013 temporarily limited pre-hospital antiemetic provision associated with hospitalization at lower gestational length and indication of an increase in termination of pregnancy.

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Section: Discussionmentioning

confidence: 99%

Antiemetic treatment of hyperemesis gravidarum in 1,064 Norwegian women and the impact of European warning on metoclopramide: a retrospective cohort study 2002–2019

Erdal

Holst

Heitmann

et al. 2022

BMC Pregnancy Childbirth

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Prevalence and causative drugs of drug-induced Parkinsonism in pediatric patients

Jeon

Lee

Kwon

2023

Eur Child Adolesc Psychiatry

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Signal Detection of Adverse Event of Metoclopramide in Korea Adverse Event Reporting System (KAERS)

Jang

Lee

Jeong

et al. 2023

Korean J Clin Pharm

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Background: This study was aimed to identify the safety signals of metoclopramide in Korea Adverse Event Reporting System (KAERS) database by proportionality analysis methods. Methods: The study was conducted using Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through KAERS. Signals of metoclopramide that satisfied the data-mining indices of proportional reporting ratio (PRR), reporting odds ratio (ROR) and information component (IC) were defined. The detected signals were checked whether they included in drug labels in the Ministry of Food and Drug Safety (MFDS), U.S. Food and Drug Administration (FDA) and Micromedex ® . Results: A total number of drug AE reports associated with all drugs of data in this study was 2,665,429. Among them, the number of AE reports associated with metoclopramide was 22,583. Forty-two meaningful signals of metoclopramide were detected that satisfied with the criteria of data-mining indicies. Especially neurological signals including extrapyramidal reactions, represented in the safety letter of regulatory agencies were identified in this study. Conclusion: Neurological signals of metoclopramide including extrapyramidal reactions were detected. It is believed that this search for signals can contribute to ensuring safety in the use of metoclopramide.

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<p>Effects of a Safety Letter on Metoclopramide Use in Korea: An Interrupted Time-Series Analysis</p>

Cited by 3 publications

References 27 publications

Antiemetic treatment of hyperemesis gravidarum in 1,064 Norwegian women and the impact of European warning on metoclopramide: a retrospective cohort study 2002–2019

Antiemetic treatment of hyperemesis gravidarum in 1,064 Norwegian women and the impact of European warning on metoclopramide: a retrospective cohort study 2002–2019

Prevalence and causative drugs of drug-induced Parkinsonism in pediatric patients

Signal Detection of Adverse Event of Metoclopramide in Korea Adverse Event Reporting System (KAERS)

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