Pfizer’s headache with its popular smoking cessation drug Chantix is intensifying. After the drugmaker halted global distribution this summer and then recalled more than a dozen lots in the United States, the company is now recalling all lots nationwide.
Pfizer Thursday noted it is expanding its recall of Chantix at the consumer level to include all batches of the drug at doses of 0.5 mg and 1 mg. The company is recalling the drug as a “precautionary measure” because the drug contains unacceptable levels of N-nitroso-varenicline, a type of nitrosamine, and because there are now “alternative suppliers” of the drug to the United States.
Nitrosamines are found in water and foods, including grilled and salted meats, Pfizer explains. While everyone is exposed to them in their lifetime, nitrosamines can cause cancer at high levels of exposure over time.
RELATED: Pfizer Withdraws 12 Batches of Chantix Over Carcinogenic Concerns After Suspending Global Shipments Last Month
Pfizer’s Chantix mess began this summer, when the company announced in June that it was halting global shipments after tests revealed the impurity. At the time, a spokesperson said the company believed the drug’s benefits “outweigh the very low potential risks, if any, posed by nitrosamine exposure” of the drug.
Then, a month later, Pfizer recalled 12 lots in the United States. The drugmaker further expanded its recall in August.
RELATED: Pfizer Stops Global Distribution of Chantix After Testing Flag Impurities
Chantix’s supply disruptions ultimately triggered a shortage. In response to these supply issues, the FDA in July authorized Apotex will import generics from Canada. Last month, the agency approved a US generic of Endo’s By Pharmaceutical.
First approved in 2006, Pfizer’s smoking cessation drug grossed $ 919 million last year.