The Spanish Agency for Medicines and Health Products (AEMPS) has ordered the withdrawal of various batches of Champix medicine, manufactured by Pfizer, in what supposes its indefinite elimination from the Spanish market.
Pfizer indefinitely recalls most popular smoking cessation drug after detecting a carcinogenic compound
This drug based on varenicline, a substance that calms anxiety and nicotine syndrome in abstinence smokers, and gives a bad taste to tobacco in those who relapse, had impurities of nitrosamines, at levels higher than what is allowed, such as explains the AEMPS in its informative note.
In it, the agency clarifies that it already published on July 6, 2021 the ICM Informative Note (CONT) 05/2021, in which he reported the stoppage of the distribution of new Champix units while the presence of the aforementioned impurity N-nitrosovarenicline in the drug was investigated.
Likewise, the AEMPS reported the preventive recall of three batches due to the detection of N-nitrosovarenicline at levels higher than the limit established by the company Pfizer, which estimated that supply would be reestablished in September of this year.
Treatment should not be started
Taking into account the available data, no immediate risk has been identified for patients treated with this medicine. However, the evaluation carried out at European level has established a more restrictive limit for the presence of this impurity. This supposes the extension of the withdrawal from the market in a preventive manner of all the lots that exceed this limit.
In Spain, the lots affected by the recall are all of which can currently be found in wholesale warehouses and pharmacy offices, which are indicated in the pharmaceutical alert R_19 / 2021 published on the AEMPS website.
Considering that the company has not provided a new reset date, no new treatments should be started until the drug is available on the market again.
The affected lots are:
- CHAMPIX 0.5 mg FILM-COATED TABLETS, 56 tablets (NR: 06360001, CN: 656184)
- CHAMPIX 0.5 mg and 1 mg film-coated tablets 11x 0.5 mg + 14 x 1 mg + 28 x 1 mg (NR: 106360023, CN: 697864)
- CHAMPIX 1 mg film-coated tablets 56 tablets (NR: 106360016, CN: 697866)
- CHAMPIX 1 mg film-coated tablets 112 tablets (NR: 106360022, CN: 697867)
As long as the supply problem persists, and given the possibility of not being able to complete the treatment due to the absence of the drug on the market, the AEMPS recommends that patients who are being treated with CHAMPIX, contact your prescribing doctor to determine the feasibility of using other marketed treatments for nicotine dependence.
Champix is the reference medicine subsidized by the regional health services of several communities, including Castilla y León, the Basque Country, Catalonia or the Valencian Community.
What are nitrosamines?
Nitrosamines are considered by the WHO as carcinogenic substances and are the reason why sausages and red meat are considered as foods that should be consumed with a lot. moderation.
The maximum production of nitrosamines in meats, however, is achieved with the highest cooking temperatures, between 95 and 185 degrees. Something similar happens with barbecue meat, a process that can also produce other carcinogens called heterocyclic amines, something that is easily solved by avoiding overcooked meat and marinating it before grilling.
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