After 14 years of being available for consumer use, Pfizer is recalling their popular anti-smoking drug Chantix.
Daily Mail reports- Pfizer has recalled its popular anti-smoking drug Chantix after it was found to contain high levels of cancer-causing agents called nitrosamines.
According to a notice posted on the Food and Drug Administration’s (FDA) website Thursday, the drugmaker is ‘voluntarily recalling all lots of Chantix 0.5mg and 1mg tablets to the patient level due to the presence of a nitrosamine, N-nitroso-varenicline (NDMA), at or above the FDA interim acceptable intake limit’.
Then, in an update posted on Friday, the FDA advised ‘patients taking recalled varenicline to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different treatment’.
‘The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline,’ it added.
Pfizer paused the distribution of Chantix back in July after finding elevated levels of nitrosamines in the pills and announced it was recalling 12 lots of the anti-smoking drug.
The drug giant – currently best known for its COVID vaccine – insisted there was no immediate risk to patients taking this medication and said the recall is out of an abundance of caution.
In the past, the US drug regulator has reached out to companies whose drugs had NDMA over accepted levels.
Chantix was approved by the FDA in May 2006 as a prescription medication that helps adults aged 18 and over quit smoking and is used for 12 to 24 weeks.
Pfizer said in its July 2021 release that people who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke.
Nitrosamines are naturally occurring organic compounds found in a variety of foods, including meat, dairy, and vegetables, according to the FDA. Everyone is exposed to the chemicals at some level.
However, if ingested in high amounts over long periods of time, nitrosamines could increase someone’s risk of developing cancer.
Pfizer didn’t indicate how the nitrosamines got in Chantix. The source of the chemicals in medication could come from its manufacturing process, its chemical structure or even the conditions under which they are stored and packaged.
Pfizer first announced that it was planning a recall of the drug on June 24 after discovering the likely carcinogen.
On June 16, 2020, it was announced that the first doses of the COVID-19 vaccine were going to be offered elderly patients and other vulnerable populations.
On December 18, 2020, the Pfizer COVID-19 vaccine received emergency use authorization.
On August 23, 2021, Pfizer’s COMIRNATY (COVID-19 Vaccine, mRNA) was approved.
Pfizer’s COVID-19 vaccine approved under Emergency Use Authorization (EUA) and the COMIRNATY vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.
So, what are the ingredients in the vaccine?
According to the FDA website, the Pfizer COVID vaccines contain the following ingredients: The vaccine includes the following ingredients: mRNA, lipids ((4- hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
How do we know all of the ingredients used to create the COVID-19 vaccinations are safe? Do you trust the pharmaceutical companies making these vaccines?
No comments:
Post a Comment