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  • Varenicline

    Marketed in the UK by Pfizer since 2006, varenicline (Champix) was an important stop smoking aid until 2021 when it was withdrawn on safety grounds. Currently only unlicensed varenicline, which does meet safety standards, is available in the UK (see below) but there are some generic varenicline licenses granted, although the medications are not available. We will keep you informed of developments.

    Unlicensed varenicline

    Following the initial disruption to supply of varenicline (Champix) in June 2021 because of the presence of nitrosamines above the acceptable level of daily intake, Pfizer announced a wholesale and pharmacy recall of Champix in October 2021.

    A nitrosamine-compliant, unlicensed varenicline supply is now available in the UK and the documents below give details of this medication and how it can be obtained.

    We asked Thistle Pharma (who is the supplier of this unlicensed varenicline) questions and their answers are reproduced below for services, individual stops smoking practitioners and other health professionals, and for patients.

    Guidance on alternatives to Champix

    28th October 2021
    Today the Department of Health and Social Care issued an updated Supply Disruption Alert confirming that there is no resupply date of varenicline from Pfizer and no alternative supplier. We have updated our guidance document below.

    14th October 2021.
    Pfizer have announced a wholesale and pharmacy recall of Champix. We understand that supply of varenicline will not be reinstated in the short term and so stop smoking services, health care professionals and smokers should all plan to use an alternative stop smoking medication such as combination NRT or bupropion (Zyban). We have updated our guidance document below.

    18th June 2021.
    It is worth remembering that we simply don’t have scientific evidence for the clinical situation facing clients having to switch from Champix mid-course to an alternative stop smoking medication, we’re making a best judgement call. We will update the guidance as necessary and date the document link below whenever an edit has been made.

    The second attachment contains the questions we've been asked about helping clients to switch from Champix, and our answers, since news of the supply problems were announced.

    16th June 2021.
    The NCSCT produced clinical guidance on helping clients to switch from Champix (e.g. to combination NRT) in response to supply issues with Champix announced by Pfizer.

    Varenicline (Champix)

    Please click on the link below to access the full Summary of Product Characteristics (SPC) where you can find all the information on usage, side effects, and drug interactions of varenicline (Champix).


    Varenicline SPC update

    This briefing reports on the findings of the large and comprehensive EAGLES study into the safety and efficacy of varenicline, and on the changes to the summary of product characteristics.

    Varenicline: effectiveness and safety

    Despite the evidence on safety and efficacy, getting some local medicines management and prescribers to accept varenicline as an equal first-line treatment option was in some cases difficult.

    This briefing is intended as a resource for commissioners, managers and staff of stop smoking services and is set out as answers to a series of questions.

    Cardiovascular disease and varenicline (Champix)

    In light of trials reporting on the incidence of cardiovascular serious adverse events among those using varenicline and a call to evaluate the association of cardiovascular serious adverse events with the use of varenicline, two recent meta-analyses have reviewed existing evidence.

    Whilst findings were not uniform, based on the findings of these reviews, the risk of cardiovascular events associated with the use of varenicline is judged to be minimal and clinically insignificant.

    Note: The recent changes to the service product characteristics (SPC) for varenicline do not substantially change the points raised in this briefing nor the advice that it is safe and effective.