Stocks of the smoking cessation drug, Champix (varenicline), will be unavailable for contractors to order indefinitely, the Department of Health and Social Care (DHSC) has said.
The announcement follows a recall of the medicine last month (14 October) after the levels of N-nitroso-varenicline — an NDMA — were found to be above the acceptable level set by the MHRA.
NDMA has been identified as a risk factor in the development of certain cancers and has genotoxic potential.
In the alert, published last week (28 October), DHSC said there was ‘no date for resupply of Champix or availability of varenicline products until further notice’.
There have been ongoing supply issues of Champix since June, following several global regulatory investigations relating to the presence of nitrosamine impurities above Pfizer’s acceptable level of daily intake in numerous batches.
Pfizer, the sole supplier of Champix, said: ‘For those patients currently prescribed Champix, we believe the benefits outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime.’
Advice for pharmacists
Pharmacists should stop dispensing the affected products (Champix 0.5mg and 1mg tablets) immediately, quarantine all remaining stock and return it to the supplier, the DHSC explained.
No new patients should be initiated on Champix and patients who are currently taking this medication will require a review and switching to nicotine replacement therapy (NRT), the alert also explained.
Prescribers starting patients on smoking cessation treatments should consider prescribing NRT or bupropion 150mg prolonged-release tablets.
It comes as pharmacies will be able to begin offering a smoking cessation advanced service from January 2022.
The new service has been introduced as part of year three of the five-year community pharmacy contractual framework alongside a hypertension case-finding service.
Last month (29 October), the Government announced E-cigarettes may be able to be prescribed on the NHS to help slash high smoking rates across the UK.