A Pennsylvania woman has filed a complaint in a federal Pennsylvania court that alleges that Pfizer’s drug Chantix (varenicline), an anti-smoking medication, is contaminated with a carcinogen that’s very similar to the contaminant that forced the recall of the popular heartburn drug, Zantac.
Plaintiff Karen Duff filed the proposed class-action complaint on Oct. 8. The complaint says that Pfizer has allegedly been peddling "adulterated, misbranded and unapproved" Chantix, according to Law360.com.
On June 25, Pfizer announced a suspension of the distribution of Chantix because of elevated levels of carcinogenic nitrosamines in some lots of the pills, WebMD reported.
Duff’s complaint also alleges that Chantix sold by Pfizer was “rendered worthless” because it was contaminated with NDMA, the carcinogenic by-product of ranitidine—the synthetic molecule in Zantac—at a level many times higher than the Food & Drug Administration’s allowable limits of the substance.
In addition, the proposed class-action complaint alleges that Pfizer had been alerted of possible NDMA contamination many years ago.
According to Law360, Duff’s complaint reads, "Defendant's VCDs were not fit for their ordinary use and defendant has been unjustly enriched through the sale of these knowingly adulterated and/or misbranded drugs.”
"Ironically,” the complaint continues, “the defendant's wrongful acts resulted in persons who sought to use smoking products less end up with a Chantix pill that contained a carcinogen."
According to WebMD, Chantix has been prescribed to over 13 million people. The drug, designed to work within a three- to six-month time frame, attaches to nicotine receptors in the brain, blocking the urge for smokers to seek a nicotine fix from combustible cigarettes or vape pens.
Pfizer brought Chantix to market in 2006 and spent over $4 million in medical journal advertisements for the drug in that year alone. In 2020, Pfizer sold nearly $1 billion worth of the drug, which cost nearly $500 for a month’s supply in 2018. The company maintains patent exclusivity protection on the drug through at least next year, Law360 reported.
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