CHAMPIX (varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline above the Pfizer acceptable daily intake limit.

Summary

• Lots of CHAMPIX batches (varenicline) that were found to contain levels of N-nitroso-varenicline above Pfizer’s acceptable level of daily intake are being recalled. As a precaution, Pfizer is pausing distribution of the medicine pending further testing. 
• Based on the available data, there is no immediate risk to patients taking this medication. 
• While EU authorities continue to assess the data, healthcare professionals should, as a precaution, not start new patients on CHAMPIX.
• The recall and pause in distribution will result in shortages of CHAMPIX. 
• For patients who are already on CHAMPIX, it may not be possible to complete treatment and healthcare professionals may consider switching treatment to an alternative.
• Alternatives will vary from market to market but may include nicotine replacement therapy (NRT) and bupropion.
• Healthcare professionals should also take into account the need to consider dose tapering, as the summary of product characteristics (SmPC) states that “At the end of treatment, discontinuation of CHAMPIX was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients.“  
• Healthcare providers should advise patients undergoing treatment not to discontinue CHAMPIX without consulting them, and to discuss any questions or concerns with their healthcare provider if needed.