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

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

June 24, 2021

SDA/2021/006

Date issued 24th June 2021

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

Useful contacts 

Stock/Ordering Queries
If there are any outstanding queries in relation to stock, please contact the Pfizer Customer Contact Centre on 0345 608 88 66.

Company Contact Point
For any questions or medical queries related to Pfizer products, please contact Pfizer Medical Information on 01304 61 61 61 or visit  Pfizer medical information

Safety Reporting
Adverse events should be reported via the Yellow Card Scheme run by MHRA. Reporting forms and information can be found here.
Adverse events should also be reported to Pfizer Medical Information on 01304 61 61 61.

The DHSC Medicine Supply Team provide a monthly update on potential supply issues affecting both primary and secondary care. This update is uploaded on the Specialist Pharmacy Services (SPS) website. To register, you will need  an NHS email address. Once set up and logged in, you will be able to access it online.

New shortages not listed on the SPS website, can be reported using our shortage reporting tool.



Posted in: ,


More Latest News >