Cargando…
Neuropsychiatric Adverse Reactions to Mefloquine: a Systematic Comparison of Prescribing and Patient Safety Guidance in the US, UK, Ireland, Australia, New Zealand, and Canada
INTRODUCTION: The antimalarial drug mefloquine (MQ) is associated with neuropsychiatric adverse reactions, some of which may predict the development of more serious effects. Although prescribing guidance in the United States drug label (DL) recommends to discontinue MQ at the onset of neuropsychiatr...
Autores principales: | , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4919134/ https://www.ncbi.nlm.nih.gov/pubmed/27240849 http://dx.doi.org/10.1007/s40120-016-0045-5 |
_version_ | 1782439215010676736 |
---|---|
author | Nevin, Remington L. Byrd, Aricia M. |
author_facet | Nevin, Remington L. Byrd, Aricia M. |
author_sort | Nevin, Remington L. |
collection | PubMed |
description | INTRODUCTION: The antimalarial drug mefloquine (MQ) is associated with neuropsychiatric adverse reactions, some of which may predict the development of more serious effects. Although prescribing guidance in the United States drug label (DL) recommends to discontinue MQ at the onset of neuropsychiatric symptoms, only certain reactions are listed in both the DL and the corresponding patient medication guide with a recommendation to discontinue or to consult a physician should they occur. To identify possible prodromal reactions for which there is complete or partial agreement in prescribing and patient recommendations, a systematic comparison of international drug safety labeling was performed. METHODS: The full text of each DL and medication guide (or equivalent) from six primarily English-speaking countries was reviewed to identify specific reactions with corresponding recommendations in drug safety labeling. Percentage agreement across the countries in corresponding recommendations was determined by MedDRA(®) high level group term (HLGT). RESULTS: Recommendations were found for reactions in 22 neuropsychiatric HLGTs. Complete or partial international agreement was found for reactions in 11 (50%) HLGTs. CONCLUSION: This analysis suggests opportunities for physicians to improve patient counseling and for international drug regulators to clarify language in MQ safety labeling to reflect national risk–benefit considerations. |
format | Online Article Text |
id | pubmed-4919134 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-49191342016-07-12 Neuropsychiatric Adverse Reactions to Mefloquine: a Systematic Comparison of Prescribing and Patient Safety Guidance in the US, UK, Ireland, Australia, New Zealand, and Canada Nevin, Remington L. Byrd, Aricia M. Neurol Ther Original Research INTRODUCTION: The antimalarial drug mefloquine (MQ) is associated with neuropsychiatric adverse reactions, some of which may predict the development of more serious effects. Although prescribing guidance in the United States drug label (DL) recommends to discontinue MQ at the onset of neuropsychiatric symptoms, only certain reactions are listed in both the DL and the corresponding patient medication guide with a recommendation to discontinue or to consult a physician should they occur. To identify possible prodromal reactions for which there is complete or partial agreement in prescribing and patient recommendations, a systematic comparison of international drug safety labeling was performed. METHODS: The full text of each DL and medication guide (or equivalent) from six primarily English-speaking countries was reviewed to identify specific reactions with corresponding recommendations in drug safety labeling. Percentage agreement across the countries in corresponding recommendations was determined by MedDRA(®) high level group term (HLGT). RESULTS: Recommendations were found for reactions in 22 neuropsychiatric HLGTs. Complete or partial international agreement was found for reactions in 11 (50%) HLGTs. CONCLUSION: This analysis suggests opportunities for physicians to improve patient counseling and for international drug regulators to clarify language in MQ safety labeling to reflect national risk–benefit considerations. Springer Healthcare 2016-05-30 /pmc/articles/PMC4919134/ /pubmed/27240849 http://dx.doi.org/10.1007/s40120-016-0045-5 Text en © The Author(s) 2016 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Nevin, Remington L. Byrd, Aricia M. Neuropsychiatric Adverse Reactions to Mefloquine: a Systematic Comparison of Prescribing and Patient Safety Guidance in the US, UK, Ireland, Australia, New Zealand, and Canada |
title | Neuropsychiatric Adverse Reactions to Mefloquine: a Systematic Comparison of Prescribing and Patient Safety Guidance in the US, UK, Ireland, Australia, New Zealand, and Canada |
title_full | Neuropsychiatric Adverse Reactions to Mefloquine: a Systematic Comparison of Prescribing and Patient Safety Guidance in the US, UK, Ireland, Australia, New Zealand, and Canada |
title_fullStr | Neuropsychiatric Adverse Reactions to Mefloquine: a Systematic Comparison of Prescribing and Patient Safety Guidance in the US, UK, Ireland, Australia, New Zealand, and Canada |
title_full_unstemmed | Neuropsychiatric Adverse Reactions to Mefloquine: a Systematic Comparison of Prescribing and Patient Safety Guidance in the US, UK, Ireland, Australia, New Zealand, and Canada |
title_short | Neuropsychiatric Adverse Reactions to Mefloquine: a Systematic Comparison of Prescribing and Patient Safety Guidance in the US, UK, Ireland, Australia, New Zealand, and Canada |
title_sort | neuropsychiatric adverse reactions to mefloquine: a systematic comparison of prescribing and patient safety guidance in the us, uk, ireland, australia, new zealand, and canada |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4919134/ https://www.ncbi.nlm.nih.gov/pubmed/27240849 http://dx.doi.org/10.1007/s40120-016-0045-5 |
work_keys_str_mv | AT nevinremingtonl neuropsychiatricadversereactionstomefloquineasystematiccomparisonofprescribingandpatientsafetyguidanceintheusukirelandaustralianewzealandandcanada AT byrdariciam neuropsychiatricadversereactionstomefloquineasystematiccomparisonofprescribingandpatientsafetyguidanceintheusukirelandaustralianewzealandandcanada |