Pfizer Voluntarily Recalls All Batches of Smoking Cessation Drug Chantix (Varenicline) in the U.S. Due to Carcinogen Contamination
Pfizer
Pharmaceutical R&D Developer
Source: PharmaCube Info
Author: Shibei
On September 16, Pfizer announced the recall of all batches of the smoking cessation drug Chantix (Chinese brand name: Changpei, generic name: varenicline, varenicline tartrate) 0.5 mg and 1 mg tablets in the United States due to elevated levels of carcinogenic impurities.
In a statement, Pfizer said that this action was taken due to the detection of the carcinogenic nitrosamine impurity (N-nitroso-varenicline) at or above the acceptable intake limit set by the FDA. Alternative suppliers have already been approved in the United States.
Pfizer added that while long-term exposure to nitrosamines could theoretically increase the risk of cancer in humans, there is no immediate risk to patients taking this medication. The company further stated that the health benefits of smoking cessation outweigh the theoretical potential carcinogenic risk posed by nitrosamine impurities in varenicline.
In June this year, this US pharmaceutical giant suspended global sales of Chantix, stating that nitrosamine levels exceeded the "acceptable" daily intake.
In 2020, Chantix generated $919 million in sales revenue for Pfizer, representing a year-on-year decrease of approximately 17.0%.
*Disclaimer: This article was written by a contributing author to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.
