In June 2021, Pfizer, Inc. announced that it will be halting worldwide distribution of its smoking-cessation drug Chantix after testing evidenced unacceptable levels of nitrosamines (probable human carcinogens) in the pills. In addition, Pfizer is also recalling multiple lots of the medication.
Pfizer said that the pause in distribution is out of an abundance of caution pending further testing. Pfizer’s spokesman, Steven Danehy, commented on the announcement: “The benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime.” Varenicline is the generic form of Chantix.
What is Chantix?
The anti-smoking medication Chantix was approved by the U.S. Food and Drug Administration (FDA) in May 2006 as a prescription medication which, used along with support, is intended to help adults over 18 quit smoking. The medication is typically used for 12 to 24 weeks.
The FDA has asked pharmaceutical companies to test their products for nitrosamines after one called N-nitrosodimethylamine (NDMA) was discovered in multiple popular medications, including blood pressure medication Valsartan and heartburn medication Zantac and its generic form (Ranitidine). The discovery of NDMA in these medications led to global drug recalls, and the FDA has made it clear that nitrosamine levels in drugs should not exceed a theoretical excess cancer risk of 1 in 100,000.
Pfizer has not announced which nitrosamines were found in Chantix or how the probable human carcinogen got into the pills.
How GoldenbergLaw Can Help
If you or a loved one have been harmed by a dangerous drug, contact the Dangerous Drug Attorneys at GoldenbergLaw today. We have more than 30 years of experience holding manufacturers accountable and giving our clients the Gold standard of justice. Contact us today for a free consultation and leave the sleepless nights to us!