The presence of an impurity in the drug Champix (varenicline) forces the American laboratory Pfizer, which develops and manufactures it, to withdraw all the batches from the pharmaceutical departments, putting the treatment out of stock.
What is the impurity detected?
In mid-July, the National Medicines Safety Agency, ANSM, published a note intended for all health professionals, from general practitioners to tobacco specialists, including pharmacists. In the note which was sent to them, it is indicated that Champix batches contain the impurity N-nitroso-varenicline, present “ at a rate greater than the daily limit considered acceptable by Pfizer. This decision follows a quality control carried out by the laboratory. This substance is a nitrosamine, derived from nitrites and nitrates, which are ” probably »Carcinogenic to humans. It is not present only in the drug Champix. It is found at very low levels in water and certain foods, such as smoked, cured or grilled meats. It is also possible to discover it in dairy products and vegetables, as indicated by the ANSM. Gold, “ Nitrosamine impurities can increase the risk of cancer for people who are exposed to them beyond acceptable limits for long periods of time. “
This is why, as a precautionary measure, the ANSM, the EMA (American Medicines Agency) and the pharmaceutical giant Pfizer have collegially decided to temporarily stop the distribution of the drug Champix. This shutdown will last at least as long as the results of additional tests which are currently underway by the European authorities are obtained.
A reassuring speech
There is a substance in the medicine Champix that binds to nicotine receptive cells in the brain. As a result, smoking cessation symptoms and associated notions of pleasure are reduced. The treatment is contraindicated in people with a history of mental disorders in particular because of the many side effects it causes. However, Pfizer clarified that “ Based on the available data, there is no immediate risk for patients treated with this medicine.. “
What if you are currently on Champix?
Do not stop treatment without medical advice
The product being out of stock, it will therefore be impossible to have it delivered. Patients who have started this treatment will therefore not be able to complete it. However, it is strongly advised not to stop it without obtaining medical advice. In fact, stopping treatment should be gradual, especially in smokers at high risk of relapse. It can also be caused by the occurrence of significant side effects, such as “ increased irritability, urge to smoke, depression, and / or insomnia ”, what happened “For at most 3% of patients. ”
Turn to alternatives
It is recommended that patients consult their doctor so that they can present them with alternatives to Champix. To quit smoking, there are two main remedies: nicotine replacement therapy or bupropion (ZYBAN). The latter, like the Champix, is rather reserved for very dependent smokers and whose other means have failed. It decreases the urges associated with the urge to smoke, but the side effects are numerous.
