Canada Health announced that Pfizer Korea had stopped its global distribution of the drug company’s nicotine addiction therapy drug Champix. Pfizer Korea initiated the distribution stoppage to “dispel concerns over the treatment’s N-nitroso varenicline impurities.” N-nitroso varenicline is considered a carcinogenic substance.
Industry insiders reported to Koreabiomed.com last Wednesday that Pfizer Korea sent an official letter to its drug distributors that Champix 0.5mg and 1mg will be out of stock “due to global distribution disruption.” However, Pfizer Korea also stated that the company’s decision to halt the distribution of the drug was a preemptive move designed to ease the domestic consumers’ concerns.
According to Koreabiomed.com, the supply stoppage follows the Ministry of Food and Drug Safety statement that Canada Health officials recalled Pfizer’s Champix due to N-nitroso varenicline levels exceeding Canada’s legal limit. This N-nitroso varenicline level limit is not used in Korea, and the ministry stated that it had already investigated anti-nicotine therapies that use varenicline back on June 15, 2021.
The Canadian recall affected the medications manufactured at Pfizer’s manufacturing plant in Quebec, Canada. Pfizer Korea stated that its supply of Champix comes from Germany. Pfizer Korea emphasized that the distribution stoppage was only a precautionary measure because these impurities can arise during the manufacturing process of the finished product. Pfizer Korea said it would stop the supply as the company conducts testing and inspection for safety.
Pfizer Korea believes that Champix’s benefits “outweigh the potential risk of exposure to nitrosamines via varenicline,” Pfizer stated that the company had installed a safety profile after initiating a robust clinical program. Pfizer Korea asserted that the company had not discovered any evidence that their drug has cancer-related issues through previous clinical trials and subsequent use during smoking cessation programs. Pfizer Korea reiterated that smokers are “15 to 30 times more likely to develop lung cancer than nonsmokers.”
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