September 30, 2021
Pharmaceutical giant Pfizer moved from pausing production to halting the manufacture of their popular anti-smoking drug, Chantix following finding the drug contains high levels of the “probable human carcinogen” nitrosamine. The voluntary recall of all lots of .5 mg and 1 mg Chantix (varenicline) was issued together with the recommendation that patients consult their health care providers.
Nitrosamine in significant levels was found in Chantix. Nitrosamine has been determined to be a carcinogen (cancer-causing) in animal testing and is classified as a probable human carcinogen by the World Health Organization. This year the FDA updated its pharmaceutical manufacturing standards “to reduce and mitigate nitrosamine impurities in active pharmaceutical ingredients and drug products.”
The FDA has identified multiple potential sources of nitrosamine in pharmaceutical products including manufacturer use of impure products, cross-contamination, and a lack of quality control and emphasizes that “manufacturers of … drug products should take appropriate measures to prevent unacceptable levels of nitrosamine impurities in their products.”
Pfizer originally paused the distribution of the drug in June, citing “an abundance of caution and further testing.” Although the company states that there is no immediate risk to patients taking Chantix, they have advised patients to consult with their health care providers for alternative treatments or medications. Distributors and wholesalers have been asked to stop the use and distribution of the tablets over the concerns.
The FDA had initially approved Chantix in May of 2006 as a prescription medication to help adults over the age of 18 to quit smoking and is typically used for 12-24 weeks. Noting Pfizer’s recall, the FDA states that “there is no immediate risk to people currently taking the drug” and that the “benefits of quitting smoking still outweigh any cancer risk from Chantix.”
If you have taken the prescription drug Chantix and have developed cancer after long-term use, you may be entitled to compensation. The attorneys at Cellino Law have decades of experience fighting against pharmaceutical companies which have produced defective or contaminated drugs. Contact us today for a free consultation.