In 2021, varenicline, the most effective single drug for quitting smoking, was withdrawn from the market in the UK because impurities were found at greater levels than is considered safe.
Authors
- Jonathan Livingstone-Banks
Lecturer & Senior Researcher in Evidence-Based Healthcare, University of Oxford
- Dimitra Kale
Senior Research Fellow, Health Psychology, UCL
- Lion Shahab
Professor in Health Psychology, UCL
Rapidly, varenicline (then sold under its brand names, Champix and Chantix) became unavailable. This was a disaster for public health. Research from University College London estimated that varenicline being unavailable resulted in about 1,890 more avoidable deaths each year because fewer people were successfully quitting smoking.
But there was hope. Cytisine (also known as cytisinicline), a naturally occurring plant-based product that had been used for decades in eastern Europe, and more recently to great effect elsewhere in the world, was licensed in the UK and made available from January 2024 .
Even so, there was an extended period when neither were available to people trying to quit smoking in the UK (and in other countries, too). But in the UK at least, things were looking up. Based on a limited but growing body of evidence, cytisine probably works as well as varenicline at helping people quit smoking, and it may be better tolerated with fewer side-effects.
It may also appeal to more smokers who may want to use a natural product rather than a drug designed in a lab. So, with varenicline withdrawn and a similarly effective treatment available, we should have seen lives saved as people who would have taken varenicline were encouraged to try cytisine instead.
Why isn't anyone prescribing it?
This didn't happen. Cytisine - despite now being licensed and available in the UK - is still shockingly underused .
Since January 2024, only 0.2% of people trying to quit smoking have used it (the same proportion that used it in 2018, when it wasn't even officially available in the UK). Official NHS data from people accessing stop-smoking services in England confirm that only 0.7% were prescribed cytisine in 2024.
So why is this? High-profile trials continue to show cytisine's effectiveness for quitting smoking (and even for quitting vaping ).
Maybe cytisine's relatively complex dosing schedule puts people off. Cytisine starts with six pills a day (one every two hours) and gradually tapers off over a few weeks: more confusing and less convenient than one-a-day varenicline.
Another possibility is that the public's attention has shifted. With so much focus in recent years on vaping as a smoking cessation aid, prescription drugs for smoking cessation may have fallen off the radar.
It could also be that GPs are reluctant to prescribe cytisine because of its cost and the assumption that local authorities should pay for it, not primary care. While it was once hoped that due to its low-cost availability in eastern Europe , it would become the "aspirin of smoking cessation drugs", the licensed product in the UK is now as or more expensive than other drugs .
But the simplest explanation is probably the most accurate: not enough people know about cytisine. People who smoke, GPs, pharmacists and even stop-smoking services may not know it's an option. And if no one is talking about it, no one is prescribing it. And even if they do know about it, there may be a lack of confidence in using or prescribing it because it is a new drug.
That's a problem. The UK government has made the shift from treating illness to preventing it a central part of its health strategy. Smoking remains the leading cause of preventable death in the country and the world. If we're serious about prevention, then effective smoking cessation support must be top of the agenda.
Now, varenicline is available again (without its brand names and reformulated to remove the impurities). This is welcome news, but only 1.1% of past-year smokers reported using varenicline. That's only a quarter of the number from before its withdrawal .
This raises an important question: should we return to prescribing varenicline by default, or is it time to consider cytisine as a first-line treatment? Researchers are continuing to learn more about cytisine, but as the evidence in favour of cytisine grows, maybe it needs a PR campaign for both prescribers and people who smoke.
None of this is to say that cytisine is a miracle cure, or that it will work for everyone. But that's true of every way to help people quit smoking. Quitting smoking is hard, and people trying to quit need more options, not fewer, and those options need to be visible and accessible.
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Jonathan Livingstone-Banks has received funding from the US National Institutes of Health (NIH), the National Institute for Health and Care Research (NIHR) and Cancer Research UK (CRUK).
Dimitra Kale receives salary support from Cancer Research UK.
Lion Shahab is a HEFCE funded member of staff at University College London. In the past, he has received honoraria for talks, an unrestricted research grant and travel expenses to attend meetings and workshops from Pfizer and an honorarium to sit on advisory panel from Johnson&Johnson, both pharmaceutical companies that make smoking cessation products. He has acted as paid reviewer for grant awarding bodies and as a paid consultant for health care companies. Other research has been funded by the Department of Health, UKRI, a community-interested company (National Centre for Smoking Cessation) and charitable sources (Cancer Research UK, Yorkshire Cancer Research). He has never received personal fees or research funding of any kind from alcohol, electronic cigarette or tobacco companies.
