Gastrointestinal adverse effects of varenicline at maintenance dose: a meta-analysis

Leung, Lawrence C.; Patafio, Francis M.; Rosser, Walter

doi:10.1186/1472-6904-11-15

Cited by 22 publications

(19 citation statements)

References 36 publications

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“…In 2007-2008, the EMA, the Medicines and Healthcare Products Regulatory Agency UK/ Committee for Medicinal Products for Human use (MHRA/ CHMP), and the FDA issued alerts regarding potential adverse events (e.g. signs of gastrointestinal side effects) [56], psychiatric disorders (e.g. anxiety, depressed mood, irrational behavior, drowsiness, abnormal dreams, sleepwalking, and occasional suicidal thoughts and behavior), and increased perception of colors.…”

Section: Vareniclinementioning

confidence: 99%

Faster drug approval: challenges for safety

Preziosi

2016

Expert Opinion on Drug Safety

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More rapid drug premarketing procedures pose a challenge for regulatory agencies in terms of innovation and improving real-world safety and effectiveness Areas covered: This review considers the blockbuster drugs used over the previous fifteen years with adverse reactions after marketing, the elements and time span of risk identification and the measures implemented or considered, based on the existing literature and reports from the agencies Expert opinion: Risk prediction is founded on several factors: randomization, sample size, a well-established endpoint for safety, use of a comparator rather than placebo and a longer Phase-III period, in which a serious illness may be identified by early signs of alteration in the primary parenchyma with the latest biochemical, instrumental and imaging techniques. In comparative non-inferiority evaluations, increased safety should be preferred, with the exception of drugs that may be useful in serious or life-threatening diseases for which there are few or no effective existing therapies. A period of restricted use may be required to test and dispense new drugs, as well as to implement specific methods for the early detection of adverse events. It is important not to regard a new medicine axiomatically as the best treatment before it comes into wide use.

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Section: Vareniclinementioning

confidence: 99%

Faster drug approval: challenges for safety

Preziosi

2016

Expert Opinion on Drug Safety

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“…Essa substância química foi produzida em 1997 e aprovado pela FDA em 2006 (CAHILL;STEAD;LANCASTER, 2011). A vareniclina é comercializada pela Pfizer em mais de 90 países; nos Estados Unidos recebe o nome de Chantix®, e na União Europeia e no Brasil de Champix® (FAESSEL et al, 2010;LEUNG;PATAFIO;ROSSER, 2011;ERWIN;SLATON, 2014).…”

Section: -Introduçãounclassified

Varenicline: A Review of the Perspective of Health Promotion

Zaccarelli-Magalhães

Camargo

2016

Cadernos De Pós-Graduação Em Distúrbios Do Desenvolvimento

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RESUMOA vareniclina é uma substância química sintética produzida a partir do alcaloide citisina da planta Cytisus Laburnum L.; é utilizada para o tratamento de tabagismo e vem sendo bastante estudada como medicamento para o tratamento da dependência de diversas drogas devido a sua modulação em receptores colinérgicos nicotínicos do sistema nervoso central. Levando em consideração que há uma tendência de ampliação do uso clínico deste fármaco e que há poucos trabalhos relacionados aos seus possíveis efeitos comportamentais, cognitivos e motores, os objetivos deste trabalho foram revisar na literatura os seguintes tópicos sobre a vareniclina: uso clínico, mecanismo de ação e receptores, farmacocinética, efeitos colaterais, possível emprego na dependência de drogas e na memória e aprendizado. Para tanto, foi realizado levantamento bibliográfico em periódicos obtidos nas bases de dados PubMed, Scopus e ScienceDirect. Nos trabalhos de diversos autores a vareniclina mostrou-se um fármaco que apresenta efeitos benéficos aos seus usuários, tendo taxa de cessação de fumo maior do que de outros métodos. Segundo o laboratório fabricante, os efeitos colaterais apresentados são possivelmente devidos à abstinência da nicotina e não ao efeito do medicamento em si; ainda assim, esse fármaco pode ser considerado seguro devido seu baixo potencial de abuso.Palavras-Chave: vareniclina, colinérgico, tabagismo, dependência de drogas, neuromodulador. ABSTRACTVarenicline is a synthetic chemical produced from the alkaloid cytisine obtained from the plant Cytisus Laburnum L.; it is used for the treatment of smoking and has been widely studied as a drug for the treatment of dependence on various drugs due to its modulation in nicotinic cholinergic receptors of the central nervous system. Taking into consideration that there is a tendency to expand the clinical use of varenicline and that there are few studies related to possible behavioral, cognitive and motor effects, the objectives of this work were to review in the literature the following topics about varenicline: clinical use, mechanism of action and receptors, pharmacokinetics, side effects, possible addiction to drugs, memory and learning. For that a bibliographic survey was carried out in journals obtained from the PubMed, Scopus and ScienceDirect databases. In the studies of several authors, varenicline has been shown to have a beneficial effect on its users, with a higher rate of smoking cessation than other methods. According to the manufacturer laboratory the side effects presented are possibly due to nicotine withdrawal and not to the effect of the drug itself; yet this drug can be considered safe because of its low potential for abuse.Keywords: varenicline, cholinergic, smoking, drug addiction, neuromodulator. RESUMENLa vareniclina es un producto químico sintético producido a partir de la citisina alcaloide de Cytisus Laburnum planta L.; Se utiliza para el tratamiento del hábito de fumar y se ha estudiado ampliamente como un medicamento para el tratamiento de la dependencia ...

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“…The US Food and Drug Administration (FDA) has issued a series of warnings, resulting from post-marketing reports of increased risk of suicidal behaviour or depression, serious adverse cardiac events and gastrointestinal complaints including a recently added warning highlighting a small increased risk of certain cardiovascular events in smokers with pre-existing cardiac conditions. A meta-analysis of adverse gastrointestinal events by Leung et al 27 showed an increased risk after treatment with varenicline. In a review of 10 trials, Tonstad et al 28 found no evidence of a link between varenicline and serious neuropsychiatric events.…”

Section: Safety Profile Of Vareniclinementioning

confidence: 99%

“…Leung et al 27 found an association between varenicline and an increased risk of gastrointestinal events. Tonstad et al 28 found no significant association between varenicline and serious neuropsychiatric events; however, an association has been suggested for those taking varenicline who are currently experiencing depression.…”

mentioning

confidence: 99%