Chantix Recall Over Cancer Causing Chemical

Philips Respironics Recalls V60 and V60 Plus Ventilators – FDA Class I Recall
August 3, 2021
#StopAbuse: Protecting the Innocence of Our Youth
August 6, 2021
Generic Benicar tablets

August 4, 2021 – San Diego, CA.  Pfizer has yet another problem with its anti-smoking drug Chantix. The company has found some lots of the drug contain high levels of a possible carcinogen called N-nitroso-varenicline, a variant of nitrosamine.

As a public service announcement – remember to NOT stop taking your prescribed medication until you first speak to your doctor, your pharmacist can provide replacement medications or your doctor will prescribe a new medication for treating the same condition.

The recalled Chanitx lots were distributed in the United States and Puerto Rico from June 2019 to June 2021.  Pfizer has notified clients directly and asked distributers to stop all shipping.  

Pfizer is working with the FDA in announcing this drug recall, and information we pulled from the FDA website (source link below) shows the lot numbers of affected Chantix products as follows:

Pfizer’s recall Chantix lots to date:

            LOT NUMBER:                       EXPERATION DATE:

  • 00020231                             9/2021
  • 00020232                             11/2021
  • 00020357                             12/2021
  • 0020358                                01/2022
  • 00020716                             01/2022
  • 00019213                             01/2022
  • ET1607                                  01/2023
  • ET1609                                  01/2023
  • EC6994                                  01/2023
  • ET1600                                  01/2023
  • EA6080                                 03/2023
  • EC9843                                  03/2023

FDA Issues Nitrosamine Guidance for Drug Makers

 Since the FDA has learned about the contamination of Chantix lots, it’s now offering all drug manufactures a guidelines for production, testing and other procedures to help reduce all possible occurrences of possible nitrosamine contamination.  The FDA also states that the health benefits of stopping smoking outweigh the cancer risk from the nitrosamine contamination in Chantix.

(To read the document please visit this link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/control-nitrosamine-impurities-human-drugs )

Not the first time Chantix has come under FDA fire.

In July of 2011 a study provided by the Canadian Medical Association Journal showed that Chantix may increase the likelihood of having cardiovascular issues including strokes and heart attacks. This set into action law firms taking Pfizer to court for failing to warn consumers about the cardiovascular risks.

Back in 2008 the FDA alerted consumers that in a study they found and stated:

“The FDA is notifying the public that the use of Chantix(varenicline) or Zyban (bupropion hydrochloride), two prescription medicines that are used as part of smoking cessation programs, has been associated with reports of changes in behavior such as hostility, agitation, depressed mood, and suicidal thoughts or actions.”

The FDA took further action on Pfizer’s Chantix drug by applying its highest level of consumer warning, known as a Black Box Warning, label be applied to the packaging.  

Were you affected by the recalled Chantix lots?

The drug injury lawyers here at the Schmidt National Law Firm are concerned for Chantix consumers and are here to help with any issues or side effects you may face with this new Chantix recall. Pfizer has already settled out of court for earlier cases (2,000 plus) and had set aside $15,000,000 to cover those cases.

Contact us today for a confidential consultation using the 100% secure form, or you can call us directly at 1-800-631-5656.

Sources:

https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamine-varenicline-chantix

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/control-nitrosamine-impurities-human-drugs

Chantix Recall Over Cancer Causing Chemical Blog post updated on August 4, 2021.