(CNN) - In fact, the FDA recommends patients keep taking Chantix until their pharmacist provides a replacement or their doctor prescribes something else.
]https://t.co/ogzwlX9Rbx pic.twitter.com/aNqDyCVHB1
\ (@FDA_Drug_Info) July 19, 2021
…………………………………….
Company Announcement Date: September 16, 2021
Product Type: Drugs
Reason for Announcement:
N-nitroso-varenicline above acceptable daily intake level
Company Name: Pfizer
Brand Name: CHANTIX
Product Description:
Varenicline tablets
Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-include-all-lots-chantixr-varenicline-tablets-due-n
……………………………………. Chantix came on the market 15 years ago….High levels of nitrosamines have been found to cause cancer in lab animals, no studies have been done to test the effect on humans.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamine-varenicline-chantix
…………………………………..
Nitrosamines (or more formally N-Nitrosamines) are organic compounds of the chemical structure R2N−N=O, where R is usually an alkyl group. Most nitrosamines are carcinogenic in animals. https://en.wikipedia.org/wiki/Nitrosamine
No comments:
Post a Comment