The National Medicines Safety Agency (ANSM), in agreement with the European Medicines Agency (EMA) announced the recall of all Champix batches. In question ? The presence of N-nitroso-varenicline at a level above the acceptable limit set at the level of the European Union. This information was sent directly to general practitioners, specialists in cardiology, pneumology, psychiatry, addiction medicine, oncology, tobacco specialists, community pharmacists, hospital pharmacists, nurses.
What is it about ? N-nitroso-varenicline is a nitrosamine. They are among the substances probably carcinogenic to humans. “Nitrosamines can be found at very low levels in water and food, especially in smoked, dried and grilled meats, dairy products and vegetables”, recalls the ANSM in its newsletter intended for doctors .
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“No immediate risk”
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In its press release, the ANSM specifies that there is no “immediate risk for patients currently taking this drug”. A previous recall of two lots announced last July, this new recall of lots will result in out of stock for patients. For patients currently being treated with Champix, it may not be possible to complete treatment. In this case, health professionals can then consider prescribing an alternative treatment because it is not recommended to abruptly stop smoking without medical advice. “At the end of treatment, stopping CHAMPIX was associated with an increase in irritability, desire to smoke, depression, and / or insomnia in at most 3% of patients” , specify the characteristics of this drug.
What are the other solutions for patients? “Therapeutic alternatives are nicotine replacement therapy (TNS) and bupropion “, recalls the ANSM.
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