Patients taking Chantix to help them quit smoking may find the drug a bit harder to locate as multiple lots have been recalled for possible contamination with, of all things, a probable human carcinogen.
Nine lots of varenicline (the drug name for Chantix) have been recalled by Pfizer. Most of the affected lots were still in warehouses and awaiting distribution, however, the company has halted further releases of the medication into U.S. pharmacies until it can determine the extent of the contamination.
The issue is the presence of N-nitroso-varenicline, a compound known to be a probable cause of cancer in the human body. The FDA has stated that there is “no immediate risk to patients” taking the medication and that they should not discontinue its use without speaking with their pharmacist or doctor first. Doctors have been warned against distributing samples of the drug, however, and Pfizer has shown itself to be reluctant to recommend extending the recall to Chantix lots that have already found their way into pharmacies and patients’ homes.
This is not the first issue Pfizer has dealt with in regard to its popular smoking cessation drug. Chantix earned a black box warning in 2009 over a significant number of reports indicating that the drug was causing severe psychological side effects in patients, including thoughts of suicide. Pfizer asked the FDA to remove the warning in 2014 but the request was denied. The black box warning is the FDA’s gravest warning for a medication and is reserved only for those cases were continued use of a medication could lead to death.
