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Pfizer announces voluntary recall of all batches of smoking cessation drug varenicline in the U.S.

 Last Update: 2021-11-05
 Source: Internet
 Author: User

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Article source: Medical Rubik's Cube Info

Author: Shi Bei

On September 16, Pfizer announced the recall of all batches of Chantix (Chinese trade name: Changpei, generic name: varenicline, varenicline tartrate) 0.
5mg and 1mg tablets in the United States due to excessive carcinogenic substances
.

Pfizer said in a statement that it took this action because it detected that the carcinogen nitrosamine (N-nitroso-varenicline) reached or exceeded the acceptable level set by the FDA
.
There are already alternative suppliers approved in the United States

Pfizer added that although long-term intake of nitrosamines may theoretically increase the risk of cancer in humans, there is no immediate risk for patients taking this drug
.
He also stated that the health benefits of quitting smoking outweigh the theoretical potential carcinogenic risk of nitrosamine impurities in varenicline

In June of this year, the US pharmaceutical giant stopped Chantix’s global sales and pointed out that the content of nitrosamines exceeded the “acceptable” daily intake

In 2020, Chantix generated sales of US$919 million for Pfizer, a year-on-year decrease of approximately 17.

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