Medication-overuse headache: A pharmacovigilance study in France

IF 2.2 4区医学 Q3 PHARMACOLOGY & PHARMACY

Therapie Pub Date : 2024-09-01 DOI:10.1016/j.therap.2024.02.001

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引用次数: 0

Abstract

Background

Overusing medication for primary headaches or other medical conditions can lead to dependency and medication-overuse headache (MOH) as an adverse drug reaction (ADR).

Objectives

To analyse reports of ADRs associated with MOH recorded in the French national pharmacovigilance database (FPVD).

Methods

This retrospective study selected all MOH cases reported in the FPVD from January 2000 to June 2023. A search of the High-Level Group Term “headache” was performed for drugs classified under ATC codes for the musculoskeletal and nervous systems. Specific keywords were searched in report narratives to further reduce their number. Voluntary intoxication reports were excluded. Only MOH cases according to the International Classification of Headache Disorders or with a medical diagnosis of MOH were considered.

Results

Among the 2674 reports associated with the HLGT “headache”, for 649 ATC drug codes, only 234 reports correspond to MOH, primarily notified by physicians. The median age was 45 years (IQR: 32–56), with 74.4% females and approximately 61.0% having pre-existing primary headaches. In all, 53.4% of the reports were classified as serious. Among patients, 84.2% had an isolated “headache” as the ADR. One drug was suspected in 47.4% of cases, two drugs in 29.1%, and three or more in 23.5%. In total, 473 suspected drugs, corresponding to 104 active ingredients, were involved, including analgesics (63.0%), in particular, acetaminophen-containing drugs, opioids, triptans and ergots, and non-steroidal anti-inflammatory drugs (12.7%). Antiepileptics and psycholeptics were found in 6.6% and 6.1% of cases, respectively. Drug withdrawal was successful in 84.6% of drug-discontinuation cases. Warnings about MOH are mentioned in the summary of product characteristics (SmPCs) for triptans, ergots, and certain acetaminophen-containing drugs, but not other drug classes.

Conclusions

Certain drug classes show a high reporting rate of MOH and caution should be exercised when prescribing these drugs. Notably, warnings about MOH must be mentioned in the SmPC of all concerned drug classes.

查看原文本刊更多论文

药物滥用性头痛：法国药物警戒研究。

背景：过度使用药物治疗原发性头痛或其他病症可能导致药物依赖性和药物滥用性头痛（MOH）这种药物不良反应（ADR）：分析法国国家药物警戒数据库（FPVD）中记录的与MOH相关的ADR报告：这项回顾性研究选择了2000年1月至2023年6月期间FPVD报告的所有MOH病例。在高级组术语 "头痛 "中搜索了按ATC代码分类的肌肉骨骼和神经系统药物。为了进一步减少报告数量，还在报告叙述中搜索了特定的关键词。自愿中毒报告被排除在外。只有根据《国际头痛疾病分类》或医学诊断为 MOH 的 MOH 病例才被考虑在内：结果：在 2674 份与 HLGT "头痛 "相关的报告中，在 649 个 ATC 药物代码中，只有 234 份报告与 MOH 相符，主要由医生通知。年龄中位数为 45 岁（IQR：32-56），74.4% 为女性，约 61.0% 原发性头痛。53.4%的报告被归类为严重报告。在患者中，84.2%的不良反应为孤立的 "头痛"。47.4%的病例怀疑是一种药物，29.1%怀疑是两种药物，23.5%怀疑是三种或三种以上药物。共涉及 473 种可疑药物，相当于 104 种有效成分，其中包括镇痛药（63.0%），尤其是含对乙酰氨基酚的药物、类阿片、三苯氧胺和麦角类药物，以及非甾体抗炎药（12.7%）。在 6.6% 和 6.1% 的病例中分别发现了抗癫痫药和精神药物。84.6%的停药病例成功停药。三苯氧胺、麦角类药物和某些含对乙酰氨基酚的药物的产品特征概要（SmPCs）中都提到了有关MOH的警告，但其他类别的药物则没有：结论：某些药物类别的MOH报告率较高，因此在处方这些药物时应谨慎。值得注意的是，所有相关药物类别的 SmPC 中都必须提及有关 MOH 的警告。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Therapie 医学-药学

CiteScore

3.50

自引率

7.70%

发文量

132

审稿时长

57 days

期刊介绍： Thérapie is a peer-reviewed journal devoted to Clinical Pharmacology, Therapeutics, Pharmacokinetics, Pharmacovigilance, Addictovigilance, Social Pharmacology, Pharmacoepidemiology, Pharmacoeconomics and Evidence-Based-Medicine. Thérapie publishes in French or in English original articles, general reviews, letters to the editor reporting original findings, correspondence relating to articles or letters published in the Journal, short articles, editorials on up-to-date topics, Pharmacovigilance or Addictovigilance reports that follow the French "guidelines" concerning good practice in pharmacovigilance publications. The journal also publishes thematic issues on topical subject. The journal is indexed in the main international data bases and notably in: Biosis Previews/Biological Abstracts, Embase/Excerpta Medica, Medline/Index Medicus, Science Citation Index.