Key takeaways:
- In June 2021, Pfizer halted the production of smoking cessation medication Chantix (varenicline) due to the presence of unacceptable levels of nitrosamines.
- Nitrosamines are chemicals found in nature and the human body, but consuming high levels of these long-term may raise the risk of cancer.
- All batches of Chantix have been impacted by the recall.
Full Answer
Is Chantix being taken off the market?
The side effects of Chantix have become so severe that a physician has now called for the FDA to remove Chantix from the market altogether. Dr. Siegel, a Professor at Boston University, has over 25 years of experience in tobacco.
Is there a Chantix shortage?
Reason for the Shortage. Pfizer has Chantix on shortage due to a manufacturing delay to evaluate the active ingredient of the product. Pfizer has recalled all presentations of Chantix. More information on the recall can be found at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamine-varenicline-chantix.
Which lots of Chantix are recalled?
The legal battle dates back to June when Pfizer halted distribution of Chantix after finding elevated levels of a potential carcinogen. In July, the pharma giant had recalled nine lots of the drug ...
Why is Chantix on backorder?
The Chantix saga kicked off in June when Pfizer halted shipments worldwide after finding unacceptable nitrosamine levels in certain lots.
When was chantix approved?
The FDA approved Varenacline, which is marketed as Chantix, in 2006.
Does Chantix cause depression?
Other health concerns have been raised about Chantix, such as mental health side effects. In 2016 , however, researchers concluded Chantix did not appear to raise the risk of serious health disorders such as depression, anxiety, and suicidal thoughts. Adobe AudienceManager.
Is Chantix recalled?
The FDA has not issued a recall on Chantix. In Canada, however, health authorities on June 8 instituted a recall for Champix, the name under which the drug is sold in that nation. The Chantix website says it’s a three-to-six-month treatment that helps people overcome the need to smoke tobacco.
Is Chantix being recalled in 2021?
June 25, 2021 -- Pfizer is suspending distribution of the anti- smoking treatment Chantix after heightened levels of the carcinogen N-nitrosodimethylamine (NDMA) were found in some lots of the pills. The pharmaceutical company is also recalling some lots of Chantix that may have high levels of NDMA, Reuters reported.
Why is varenicline recalled?
The company is recalling varenicline because it may contain levels of a nitrosamine impurity, called N-nitroso-varenicline, above FDA’s acceptable intake limit. N-nitroso-varenicline may be associated with a potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication.
Can you quarantine varenicline?
If you have varenicline samples from this company, quarantine them, and do not provide them to patients. Contact Pfizer directly if you have questions regarding product return or disposal.
Is Pfizer recalling varenicline?
Pfizer is recalling the varenicline lots currently stored in warehouses. FDA recommended Pfizer revise its recall to the consumer level in order to take into account the product currently on the market, but the company has not yet done so.
Reason for the Shortage
Pfizer has Chantix on shortage due to a manufacturing delay to evaluate the active ingredient of the product. Pfizer has recalled all presentations of Chantix. More information on the recall can be found at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamine-varenicline-chantix. [1]
Estimated Resupply Dates
Pfizer has Chantix on back order and the company cannot estimate a release date. [1]
Implications for Patient Care
FDA is allowing temporary importation Apo-Varenicline (varenicline tartrate) from Apotex in Canada. More information on ordering the product from Apotex through a distributor or wholesaler can be found at https://www.fda.gov/media/150799/download
Safety
Abrupt discontinuation of varenicline has been associated with increased irritability and sleep disturbances, suggesting varenicline may produce mild physical dependence. [2]
Alternative Agents & Management
There are 3 medications that are primarily used in tobacco smoking cessation. These are nicotine (a variety of forms are available including patches, gum, lozenges, nasal sprays, and oral inhalers), bupropion sustained-release, and varenicline. It is suggested that varenicline is the most effective medication alone or in combination.
Updated
Updated September 18, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 24, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.
What is Chantix 2021?
Last updated on June 8, 2021. Chantix is a brand name of varenicline, approved by the FDA in the following formulation (s):
Is Chantix available in the US?
No. There is currently no therapeutically equivalent version of Chantix available in the United States. Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Chantix. These medications may be counterfeit and potentially unsafe.
When was Chantix approved?
The FDA approved Chantix in 2006, a decision then hailed by public-health officials for its potential to help curb smoking addiction. Your browser does not support the audio tag. Loading advertisement... This article is in your queue. Pfizer Inc. has suspended distribution world-wide of antismoking pill Chantix and recalled some lots ...
Is Chantix a carcinogen?
The drugmaker is doing more testing to determine whether additional Chantix lots contain elevated amounts of the likely carcinogen, known as nitrosamines, according to the spokesman. As a precaution, Pfizer suspended distribution while determining the extent of the contamination, the spokesman said. The company said it was testing lots ...
Has A Generic Version of Chantix Been approved?
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