Supply disruption alert: Champix (Varenicline) 0.5mg and 1mg tablets – Pfizer – Updated
SDA/2021/006 (U) this update supercedes the advice provided in the previous alert SDA/2021/006
Date issued 28th October 2021
Champix® (varenicline) 0.5mg and 1mg tablets – Supply Disruption
- All Champix® (varenicline) products are unavailable until further notice.
- The Medicines and Healthcare products Regulatory Agency (MHRA) initiated a class 2 medicines recall (EL 21 A/25) of all strengths of Champix® tablets (all in-date batches) on 14th October 2021 at pharmacy and wholesaler level.
- 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.
Since the original supply disruption alert (SDA/2021/006) was issued on 24th June 2021, the European Medicines Agency Committee for Medicinal Products for Human Use (EMA CHMP) have issued their decision on the acceptable limit of impurities to be present in varenicline products in Europe.
The MHRA advised that they have taken the decision to align with the CHMP’s approach on acceptable limits of nitrosamines in varenicline products and initiated a class 2 medicines recall (EL 21 A/25) of all in-date batches of Champix® (varenicline) at pharmacy and wholesaler level. This is a precautionary measure due to presence of levels of N-nitroso-varenicline above the acceptable level of intake set by both European Medicines Agency (EMA) and MHRA.
Advice for healthcare professionals
• Please quarantine all remaining stock of the specified Champix batches and return them to your supplier using your supplier’s approved process.
• Healthcare professionals should advise patients undergoing treatment to discuss any questions or concerns with their prescribing healthcare professional.
Further information can be found in the alert here
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
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.