Medicines Agency orders recall of smoking cessation drug Champix

The Spanish Agency for Medicines and Health Products (AEMPS) has ordered the withdrawal of several batches of the drug Champix, manufactured by Pfizer, which means its indefinite elimination from the Spanish market.

Pfizer indefinitely withdraws its most popular smoking cessation drug after detecting a carcinogenic compound.

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This drug based on varenicline, a substance that calms anxiety and nicotine syndrome in smokers in abstinence, and gives bad taste to tobacco in those who relapse, had impurities of nitrosamines, at levels higher than permitted, as explained by the AEMPS in its information note.

In the same, the agency clarifies that already published on July 6, 2021 the Information Note ICM (CONT) 05/2021, which reported the stop of the distribution of new units of Champix while investigating the presence of the aforementioned impurity N-nitrosovarenicline in the drug.

The AEMPS also reported the preventive withdrawal of three batches due to the detection of N-nitrosovarenicline at levels above the limit established by the company Pfizer, which estimated that the supply would be reestablished in September of this year.

Treatment should not be started

Based on the available data, no immediate risk to patients treated with this drug has been identified. However, the evaluation carried out at European level has established a more restrictive limit for the presence of this impurity. This implies the extension of the precautionary recall of all batches exceeding this limit.

In Spain, the batches affected by the withdrawal are all those that can currently be found in wholesale warehouses and farm offices.acia, which are indicated in the pharmaceutical alert R_19/2021 published on the AEMPS website.

As the company has not provided a new reinstatement date, no new treatments should be initiated until the medicine is available on the market again.

Affected batches

The affected batches 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)

While the supply problem persists, and given the possibility of not being able to complete the treatment due to the absence of the medicine on the market, the AEMPS recommends that patients who are being treated with CHAMPIX contact their prescribing physician to determine the possibility of using other commercially available treatments for nicotine dependence.

Champix is the reference medicine subsidised by the regional health services of several communities, including Castilla y León, the Basque Country, Catalonia and the Valencian Community.

What are nitrosamines?

Nitrosamines are considered by the WHO to be carcinogenic substances and are the reason why sausages and red meat are considered to be foods that should be consumed in moderation.

The maximum production of nitrosamines in meat, however, is achieved at the highest cooking temperatures, between 95 and 185 degrees. Something similar happens with barbecued 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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