Southampton Smokefree Services

Supply disruption alert: Champix (Varenicline) 0.5mg and 1mg tablets – Pfizer

Champix® (varenicline) 0.5mg and 1mg tablets – Supply Disruption

  • • All Champix® (varenicline) products are unavailable until further notice.
  • • Very limited residual stock may be available in pharmacies.
  • • Patients currently prescribed this treatment will require review and switching to nicotine replacement
  •    therapy (NRT) unless contraindicated.
  • • No new patients should be initiated on Champix® (varenicline) products.
  • • Prescribers initiating smoking cessation treatment for new patients should consider prescribing NRT or         bupropion 150mg prolonged release tablets unless contraindicated.
  • • Helping a patient to stop smoking should not be delayed if they are motivated to stop as other effective       options are available.

Pfizer, the sole supplier of Champix® , stopped the distribution of all Champix® (varenicline) 0.5mg and 1mg tablets in early June 2021. Pfizer are currently unable to confirm when resupplies will become available following global regulatory investigations relating to the presence of nitrosamine impurities above Pfizer’s acceptable level of daily intake in several lots.

Pfizer have indicated “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.”

The Medicines and Healthcare products Regulatory Agency (MHRA), who are the regulators of medicines, have advised that batches currently in the market are not subject to a recall, at this stage. This is a developing issue and further updates will be provided as the investigation progresses. Patients are advised not to stop taking their medication prior to consultation with their doctor or pharmacist, as the health risk of discontinuing the medicine is higher than the potential risk presented by the impurity.

Further information can be found in the alert here and also on the NCSCT website here.