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Chantix Recall Overview:
- Who: Pfizer, the maker of Chantix, is expanding its recall of the smoking cessation medication to all lots.
- Why: Pfizer, which already recalled some lots of Chantix, is now recalling all lots of the medication due to potentially unsafe levels of nitrosamine, a carcinogen.
- Where: The recalled lots were distributed across the United States and Puerto Rico between June 2019 and June 2021.
Pfizer is now recalling all lots of the smoking cessation medication Chantix (Varenicline) due to potentially unsafe levels of a nitrosamine, N-nitroso-varenicline — a carcinogen.
The news comes after the pharmaceutical company previously issued multiple partial recalls of the medication. The recall affects all lots of Chantix sold at the consumer level, according to the U.S. Food & Drug Administration recall announcement posted last Thursday.
“As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure,” the notice stated.
“Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options,” Pfizer said.
On June 24, Pfizer issued the first recall. The drug maker announced that it had discovered levels of N-nitrosodimethylamine — a known cancer-causing agent that is also known as NDMA — that are above an “acceptable” level of daily intake.
Pfizer said it had instructed wholesalers and distributors to stop using and quarantine the recalled lots and is setting up a way for consumers to return the recalled Chantix.
To date, Pfizer had not received any reports of adverse events related to the recall, it said.
The company said the health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.
“Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication.”
However, the latest recall expansion is not the first time Chantix has been linked to adverse health effects. Since the drug was introduced, Chantix users have reported psychological side effects such as depression, aggression, homicidal tendencies, entertaining the thought of suicide, and even suicide attempts.
Pfizer has faced a number of lawsuits by Chantix users and their family members who say the drug caused severe depression and even resulted in suicide. Others have claimed that the drug caused severe psychological side effects, including blackouts that landed one Chantix user in jail.
In 2009, the FDA placed a “black box” warning label on Chantix informing users that recent data showed the smoking cessation drug can cause depression, suicidal thoughts, attempted suicide, aggression and anger.
Two years later, in June 2011, the FDA updated the Chantix side effects warning again to include heart attack and other severe cardiovascular events.
Top Class Actions will continue to monitor the Chantix recall and keep readers updated with any developments.
Have you used Chantix? Are you concerned about the recall? Tell us about it in the comment section below.
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49 thoughts onAll Lots of Chantix Recalled by Pfizer Due to Presence of Carcinogen
Please add me also. I been on it twice since 2009. The lastest was just last year. Please, i did get a call from my pharnacy but it was after i took them all so they said not to worry about it. Im scared. Im 56 yo and not looking to get cancer. My mother passed from cancer.
I used Chantix once in 2015 and 2019.
I received from phizer company for low income persons.
I was prescribed Chantax at the Emergency room, back in 2018. I still have the bottle with some of the medication left. I did’nt help at all, and it had me hallucinating. I live in North Little Rock, Arkansas. Can I be added to the lawsuit?
I have used it several times over last 5 years and have had 2 cases of Lung cancer in last two years.
I was taking this! I was having very aggressive dreams/nightmares. Couldn’t sleep! Please add me! Stop taking due to recall! Something to try to avoid cancer, was only supplying it!
have taken Chantix on and off for the past 10 years. I have experienced severe depression suicidal ideation etc.. please include me in the potential lawsuit.
I received a letter from my pharmacy regarding the recall. I stopped taking them. Still have some left.
I would like to join this class action about Chantix. I was wondering what was going on when i was taking the pill and feeling different. I had to stop taking it because it was giving me heart palpitations too. I told my doctor about it. He had to prescribe a different medication to stop smoking. I do still have the prescribed Chantix that I was taking, just in case I will be added to this case.
I thought it was just me! I’d been on Chantix from 1/21 to 9/21. It made it easy to cut down but hard to quit because I didn’t feel like myself & it was a horrible feeling. I tried to push through it but it was a vicious cycle. My pharmacy called me a few months ago & said they had 1 more bottle & did I want it. After that, though I was down to 3 cigs a day, I started regularly smoking again, unfortunately, about 5 days off my last Chantix. The blessing, as I now see & feel it, is that I feel like myself again. When you’re on Chantix it is difficult to relate to anything.
I have been on and off Chantix the last 2 years. I get aggressive when on it.
I have used chantix numerous times and during the time they stated. Every time I have used it I have gotten depressed, irritable beyond the normal and suicidal. How do we get added to the class action list?