Supply of all Champix products, used for smoking cessation, will remain out of stock until further notice from the Medicines and Healthcare products Regulatory Agency (MHRA).
The announcement follows a medicine recall order initiated by the MHRA for “all strengths of Champix® tablets” on October 14, 2021 at pharmacy and wholesaler level.
Pfizer, the sole supplier of Champix tablets, stopped the distribution of 0.5mg and 1mg tablets in early June 2021.
The company is currently unable to confirm when supplies will resume amid global regulatory investigations relating to the presence of nitrosamine impurities above the Pfizer’s acceptable level of daily intake in several lots.
Nitrosamine is considered a cancer-causing agent.
To align with the European Medicines Agency Committee for Medicinal Products for Human Use (EMA CHMP)’s decision on the acceptable level of impurities in varenicline products, MHRA issued medicine recall for Champix.
“Pfizer Ltd are recalling specified batches (all stock) of products as 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,” the regulator said.
Advice for healthcare professionals
The regulator has advised to quarantine all remaining stock of Champix tablets and return to the supplier using supplier’s approved process.
Besides, patients who have been prescribed this treatment will need a review and switch to nicotine replacement therapy (NRT), unless contraindicated.
No new patients should be initiated on Champix® (varenicline) products, MHRA said.