Amélie Lepert, Delphine Bourneau-Martin, Bénédicte Lebrun-Vignes, Alexandra Gentil, Pierre Brunel, Ivan Berlin, Marie Briet
{"title":"伐尼克兰短缺的临床后果：法国国家药物警戒数据库的研究。","authors":"Amélie Lepert, Delphine Bourneau-Martin, Bénédicte Lebrun-Vignes, Alexandra Gentil, Pierre Brunel, Ivan Berlin, Marie Briet","doi":"10.1016/j.therap.2025.02.009","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>Varenicline is a smoking cessation therapy included in the World Health Organization (WHO) model list of essential medicines. In May 2021, the presence of N-nitroso-varenicline, a carcinogenic agent, was detected in varenicline tablets above the limits determined by the European Medicine Agency (EMA), leading to batches being recalled and causing a shortage of this drug. The aim of this study was to use pharmacovigilance data to evaluate the clinical consequences of the shortage of varenicline.</p><p><strong>Methods: </strong>Data were extracted from the French PharmacoVigilance Database using the following terms: \"varenicline (tartrate of)\", \"varenicline\" and \"tartrate of varenicline\" as the suspected, interactive, or concomitant medication from 4 April 2021 to 17 March 2023. Each case was reviewed by a pharmacovigilance expert to select only cases that involved a varenicline shortage.</p><p><strong>Results: </strong>Among the 32 included cases, the reported adverse effects were: smoking relapse (n=21), tobacco cessation failure (n=7) and tobacco withdrawal syndrome (n=2). Most of the patients presented a high level of tobacco dependence. Before the introduction of varenicline, these smokers consumed a median of 20 cigarettes per day. They did not smoke while receiving varenicline. After the shortage, the daily cigarette consumption went up to 10 in all patients treated with nicotine replacement therapy (NRT) and up to 20 when NRT was not used.</p><p><strong>Discussion: </strong>In the context of a varenicline shortage, the pharmacovigilance data confirmed the risk of smoking relapse and/or cessation failure in patients with a strong addiction to cigarettes. Given the role of smoking exposure in respiratory, cancer and cardiovascular risk, it is vitally important that the availability of this medicine is ensured. Solutions, such as the importation of alternatives produced by other brands that pass the tests for impurity quantification, may prevent the risk in this context.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2000,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical consequences of varenicline shortage: A study on the French national pharmacovigilance database.\",\"authors\":\"Amélie Lepert, Delphine Bourneau-Martin, Bénédicte Lebrun-Vignes, Alexandra Gentil, Pierre Brunel, Ivan Berlin, Marie Briet\",\"doi\":\"10.1016/j.therap.2025.02.009\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>Varenicline is a smoking cessation therapy included in the World Health Organization (WHO) model list of essential medicines. In May 2021, the presence of N-nitroso-varenicline, a carcinogenic agent, was detected in varenicline tablets above the limits determined by the European Medicine Agency (EMA), leading to batches being recalled and causing a shortage of this drug. The aim of this study was to use pharmacovigilance data to evaluate the clinical consequences of the shortage of varenicline.</p><p><strong>Methods: </strong>Data were extracted from the French PharmacoVigilance Database using the following terms: \\\"varenicline (tartrate of)\\\", \\\"varenicline\\\" and \\\"tartrate of varenicline\\\" as the suspected, interactive, or concomitant medication from 4 April 2021 to 17 March 2023. Each case was reviewed by a pharmacovigilance expert to select only cases that involved a varenicline shortage.</p><p><strong>Results: </strong>Among the 32 included cases, the reported adverse effects were: smoking relapse (n=21), tobacco cessation failure (n=7) and tobacco withdrawal syndrome (n=2). Most of the patients presented a high level of tobacco dependence. Before the introduction of varenicline, these smokers consumed a median of 20 cigarettes per day. They did not smoke while receiving varenicline. After the shortage, the daily cigarette consumption went up to 10 in all patients treated with nicotine replacement therapy (NRT) and up to 20 when NRT was not used.</p><p><strong>Discussion: </strong>In the context of a varenicline shortage, the pharmacovigilance data confirmed the risk of smoking relapse and/or cessation failure in patients with a strong addiction to cigarettes. Given the role of smoking exposure in respiratory, cancer and cardiovascular risk, it is vitally important that the availability of this medicine is ensured. Solutions, such as the importation of alternatives produced by other brands that pass the tests for impurity quantification, may prevent the risk in this context.</p>\",\"PeriodicalId\":23147,\"journal\":{\"name\":\"Therapie\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-03-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapie\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.therap.2025.02.009\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapie","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.therap.2025.02.009","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Clinical consequences of varenicline shortage: A study on the French national pharmacovigilance database.
Objectives: Varenicline is a smoking cessation therapy included in the World Health Organization (WHO) model list of essential medicines. In May 2021, the presence of N-nitroso-varenicline, a carcinogenic agent, was detected in varenicline tablets above the limits determined by the European Medicine Agency (EMA), leading to batches being recalled and causing a shortage of this drug. The aim of this study was to use pharmacovigilance data to evaluate the clinical consequences of the shortage of varenicline.
Methods: Data were extracted from the French PharmacoVigilance Database using the following terms: "varenicline (tartrate of)", "varenicline" and "tartrate of varenicline" as the suspected, interactive, or concomitant medication from 4 April 2021 to 17 March 2023. Each case was reviewed by a pharmacovigilance expert to select only cases that involved a varenicline shortage.
Results: Among the 32 included cases, the reported adverse effects were: smoking relapse (n=21), tobacco cessation failure (n=7) and tobacco withdrawal syndrome (n=2). Most of the patients presented a high level of tobacco dependence. Before the introduction of varenicline, these smokers consumed a median of 20 cigarettes per day. They did not smoke while receiving varenicline. After the shortage, the daily cigarette consumption went up to 10 in all patients treated with nicotine replacement therapy (NRT) and up to 20 when NRT was not used.
Discussion: In the context of a varenicline shortage, the pharmacovigilance data confirmed the risk of smoking relapse and/or cessation failure in patients with a strong addiction to cigarettes. Given the role of smoking exposure in respiratory, cancer and cardiovascular risk, it is vitally important that the availability of this medicine is ensured. Solutions, such as the importation of alternatives produced by other brands that pass the tests for impurity quantification, may prevent the risk in this context.
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
