No further supplies of Champix (varenicline 0.5mg and 1mg tablets) will be available until further notice
A supply disruption alert notifies practices of a current discontinuation. This is in response to global regulatory investigations relating to the presence of nitrosamine impurities above Pfizer’s acceptable level of daily intake in several lots.
Pfizer states that “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.”
Batches in the market are not subject to a recall, at this stage and patients are advised not to stop taking their medication prior to consultation with their doctor.
Prescribers should note the following advice:
- 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.