Summary of information about lots of CHAMPIX (varenicline) to be recalled due to presence of impurity N-nitroso-varenicline above the acceptable intake limit:

• All CHAMPIX (varenicline) batches that were found to contain levels of N-nitroso-varenicline above the acceptable level of intake set at EU level are being recalled.
• Based on the available data, there is no immediate risk to patients currently taking this medication.
• The recall will result in further shortages of CHAMPIX (earlier recall of several batches took place in July 2021).
• 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 professionals should advise patients undergoing treatment not to discontinue CHAMPIX without consulting them, and to discuss any questions or concerns with their healthcare professionals if needed.

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