A systematic review of possible serious adverse health effects of nicotine replacement therapy

Abstract

We conducted a systematic literature review to identify and critically evaluate studies of serious adverse health effects (SAHEs) in humans using nicotine replacement therapy (NRT) products. Serious adverse health effects refer to adverse events, leading to substantial disruption of the ability to conduct normal life functions. Strength of evidence evaluations and conclusions were also determined for the identified SAHEs. We evaluated 34 epidemiological studies and clinical trials, relating NRT use to cancer, reproduction/development, CVD, stroke and/or other SAHEs in patients, and four meta-analyses on effects in healthy populations. The overall evidence suffers from many limitations, the most significant being the short-term exposure (≤12 weeks) and follow-up to NRT product use in most of the studies, the common failure to account for changes in smoking behaviour following NRT use, and the sparse information on SAHEs by type of NRT product used. The only SAHE from NRT exposure we identified was an increase in respiratory congenital abnormalities reported in one study. Limited evidence indicated a lack of effect between NRT exposure and SAHEs for CVD and various reproduction/developmental endpoints. For cancer, stroke and other SAHEs, the evidence was inadequate to demonstrate any association with NRT use. Our conclusions agree with recent statements from authoritative bodies.Electronic supplementary materialThe online version of this article (doi:10.1007/s00204-016-1856-y) contains supplementary material, which is available to authorized users.

Leitlinie zur Diagnostik und Therapie von Patienten mit chronisch obstruktiver Bronchitis und Lungenemphysem (COPD)

“…Wie [195]. Alle Nikotinersatztherapeutika weisen eine gute Verträglichkeit bei einzelnen applikationsspezifischen Nebenwirkungen auf (Pflaster: Hautirritationen, Pflasterallergien; Kaugummi und Tablette: Reizung der Mundschleimhaut, Zunge, Rachen, Speiseröhre und Magen in Form von brennenden Schmerzen, Ulzerationen und Schluckauf; Nasenspray: Reizung der Nasenschleimhaut in Form von Brennen, Schmerzen, Atrophie) [193].…”

What lessons have we learnt about the impact of maternal cigarette smoking from animal models?

“…42,43 As such, fetal growth itself is not changed. In a recent systematic review published in 2017, 44 the only serious adverse health effect due to NRT use during pregnancy was an increase in respiratory congenital abnormalities. However, women included in this study had a high rate of chronic diseases, which can also independently affect fetal diseases.…”

“…However, women included in this study had a high rate of chronic diseases, which can also independently affect fetal diseases. 44 The low NRT dose regimen used during pregnancy may also contribute to the lack of efficacy in quitting smoking during pregnancy, which is similar to placebo. 45 This is because that NRT does not effectively control the withdrawal symptoms in most users.…”

Heat or Burn? Impacts of Intrauterine Tobacco Smoke and E-Cigarette Vapor Exposure on the Offspring’s Health Outcome

“…Furthermore, offspring from pregnant mothers using NRT during pregnancy had similar infant survival rates and slightly less developmental impairment (27%) at birth compared to the placebo group (35%) [ 41 ]. However, epidemiological evidence on the risk of adult-onset disease in offspring born to mothers using NRT during pregnancy is limited [ 25 , 41 ], and these studies failed to consider the changes in smoking behavior after NRT and the duration of NRT during pregnancy [ 42 ].…”