Pfizer recalls anti-smoking drug due to high levels of ingredient tied increased risk of cancer

[whatbogsends]

Pfizer recalled its anti-smoking drug Chantix due to high levels of an ingredient that is tied to an increased risk of cancer.

In a notice posted to the Food and Drug Administration’s (FDA) website on Thursday, Pfizer said it was recalling Chantix 0.5 mg and 1 mg tablets to the consumer level due to the presence of N-nitroso-varenicline.

Long term ingestion of N-nitroso-varenicline can be associated with a “theoretical potential increased cancer risk in humans,” the notice said. However, there is no immediate risk to patients taking the drug.

The company said it is undertaking the recall as a precautionary measure, adding that the benefits of stopping smoking “outweigh the theoretical potential cancer risk from the nitrosamine impurity."

Pfizer recalls anti-smoking drug due to high levels of ingredient tied increased risk of cancer | TheHill

Chantix was approved by the FDA in 2006.

Drug Approval Package: Chantix (Varenicline) NDA #021928 (fda.gov)

A mere 14 years later, they're recalling it due to the fact that it causes cancer.

Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content | FDA

Remember, the benefits outweigh the risk! (but we're still recalling it...)

 

[spiritfilledjm]

This makes no sense whatsoever. One is only on Chantix for 3-6 months.

 

[trunks2k]

This makes no sense whatsoever. One is only on Chantix for 3-6 months.

I can't tell if it's just an impurity as aa by product of manufacturing or an intentional ingredient. If the latter, they may have just decided they could use something else and it's just not worth using an ingredient that "may be associated with a theoretical potential increased cancer risk in humans" when consumed for a long time.

 

[spiritfilledjm]

I can't tell if it's just an impurity as aa by product of manufacturing or an intentional ingredient. If the latter, they may have just decided they could use something else and it's just not worth using an ingredient that "may be associated with a theoretical potential increased cancer risk in humans" when consumed for a long time.

After 15 years though? I mean, diet drinks and sugar free stuff contain aspartame but it's fine because it's only harmful in certain quantities. This makes no sense but, personally, I've never known anyone to take it and I've known a lot of now-former smokers so I can't imagine it's that big of a deal, it just doesn't make sense lol.

 

[whatbogsends]

After 15 years though? I mean, diet drinks and sugar free stuff contain aspartame but it's fine because it's only harmful in certain quantities. This makes no sense but, personally, I've never known anyone to take it and I've known a lot of now-former smokers so I can't imagine it's that big of a deal, it just doesn't make sense lol.

You don't need to be on it 15 years for it to cause harm. It's been on the market for 15 years before the cancer causing ingredient was recognized by the FDA as causing harm.

 

[Tanj]

So for anyone that cares about rationality and facts...

The fact that this impurity existed and could be detected was first reported in 2018.
FDA Statement on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings

And the FDA didn't update their guidance until 2021
https://www.fda.gov/media/141720/download


Which means that it took Pfizer just 3 years to go from learning that this could be a problem, to finding it existed in one of their products, to issuing a voluntary recall a few months after the guidance came out.

Sadly some posters think the FDA should have used the Obama time portal to go back 15 years.

 

[whatbogsends]

So for anyone that cares about rationality and facts...

The fact that this impurity existed and could be detected was first reported in 2018.
FDA Statement on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings

And the FDA didn't update their guidance until 2021
https://www.fda.gov/media/141720/download


Which means that it took Pfizer just 3 years to go from learning that this could be a problem, to finding it existed in one of their products, to issuing a voluntary recall a few months after the guidance came out.

Sadly some posters think the FDA should have used the Obama time portal to go back 15 years.

Just for rationality and facts, people keep telling us that the vaccines have been so thoroughly tested that there's no way there's any unknown side effects. Yet it took Chantrix 12 years of being fully on the market to identify the cancer-causing side effects, and another 3 years for them to pull the plug on it. It was causing cancer for 12 years before they even knew (or admitted to knowing) it was doing it.

This is exactly why FDA approval is meaningless.

 

[Tanj]

Just for rationality and facts, people keep telling us that the vaccines have been so thoroughly tested that there's no way there's any unknown side effects.

Ahh the bait and switch. Wondered when that was coming.

 

[cow451]

Pfizer recalled its anti-smoking drug Chantix due to high levels of an ingredient that is tied to an increased risk of cancer.

In a notice posted to the Food and Drug Administration’s (FDA) website on Thursday, Pfizer said it was recalling Chantix 0.5 mg and 1 mg tablets to the consumer level due to the presence of N-nitroso-varenicline.

Long term ingestion of N-nitroso-varenicline can be associated with a “theoretical potential increased cancer risk in humans,” the notice said. However, there is no immediate risk to patients taking the drug.

The company said it is undertaking the recall as a precautionary measure, adding that the benefits of stopping smoking “outweigh the theoretical potential cancer risk from the nitrosamine impurity."

Pfizer recalls anti-smoking drug due to high levels of ingredient tied increased risk of cancer | TheHill

Chantix was approved by the FDA in 2006.

Drug Approval Package: Chantix (Varenicline) NDA #021928 (fda.gov)

A mere 14 years later, they're recalling it due to the fact that it causes cancer.

Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content | FDA

Remember, the benefits outweigh the risk! (but we're still recalling it...)

Ok. Skip the vaccine and start smoking.

 

[cow451]

This makes no sense whatsoever. One is only on Chantix for 3-6 months.

Shhhhhh….. OP is on a roll…..

 

[HARK!]

Long term ingestion of N-nitroso-varenicline can be associated with a “theoretical potential increased cancer risk in humans,” the notice said. However, there is no immediate risk to patients taking the drug.

At least it doesn't kill anyone right away. That could cut into profits.

Chantix was approved by the FDA in 2006.

Drug Approval Package: Chantix (Varenicline) NDA #021928 (fda.gov)

Should we trust a government to protect us from corporations; when the CEOs of those corporations are often appointed to run administrations such as the FDA; and the collective government in the US owns the majority of the stock in most of those same corporations? This means that the government gets to decide who the CEOs of those corporations are.

Remember, the benefits outweigh the risk!

Does Pfizer tout the same for their Covid vax?

 

[HARK!]

This makes no sense whatsoever. One is only on Chantix for 3-6 months.

It makes as much sense to me as Chernobyl.

 

[Tanj]

and the collective government in the US owns the majority of the stock in most of those same corporations?

What are you talking about?

Here's Pfizers top share holders:
PFE - Pfizer Inc Shareholders - CNNMoney.com

Please explain how "the collective government in the US" (whatever that means) owns the majority stock

 

[cow451]

What are you talking about?

Here's Pfizers top share holders:
PFE - Pfizer Inc Shareholders - CNNMoney.com

Please explain how "the collective government in the US" (whatever that means) owns the majority stock

Hush. I want to see this goes.

 

[Trogdor the Burninator]

Just for rationality and facts, people keep telling us that the vaccines have been so thoroughly tested that there's no way there's any unknown side effects. Yet it took Chantrix 12 years of being fully on the market to identify the cancer-causing side effects, and another 3 years for them to pull the plug on it. It was causing cancer for 12 years before they even knew (or admitted to knowing) it was doing it.

This is exactly why FDA approval is meaningless.

It was pretty easy to spot that this was always going to be an anti-vax agenda post. However people take two doses of the vaccine. That's it.

It bears little resemblance to a drug that is taken at regular intervals over many months.

Plus, if Pfizer, the FDA and 'big pharma" are all involved in some conspiracy, then why did they volunteer to recall at all?

 

[Trogdor the Burninator]

It makes as much sense to me as Chernobyl.

Sorry, what?

I rate this post 3.6 out of 10. Not great, not terrible.

 

[HARK!]

What are you talking about?

Here's Pfizers top share holders:
PFE - Pfizer Inc Shareholders - CNNMoney.com

If we combine all of the stock holdings, of all of the local corporate branches (States, Counties Cities/Towns), under the umbrella government corporation; we will find that the government holds the controlling shares of most of the major corporations.

This is Part 1 of a long series, that goes into great detail on the subject. It's a good place to get started in researching this topic:

Fascism at its' best!

 

[Ana the Ist]

Pfizer recalled its anti-smoking drug Chantix due to high levels of an ingredient that is tied to an increased risk of cancer.

In a notice posted to the Food and Drug Administration’s (FDA) website on Thursday, Pfizer said it was recalling Chantix 0.5 mg and 1 mg tablets to the consumer level due to the presence of N-nitroso-varenicline.

Long term ingestion of N-nitroso-varenicline can be associated with a “theoretical potential increased cancer risk in humans,” the notice said. However, there is no immediate risk to patients taking the drug.

The company said it is undertaking the recall as a precautionary measure, adding that the benefits of stopping smoking “outweigh the theoretical potential cancer risk from the nitrosamine impurity."

Pfizer recalls anti-smoking drug due to high levels of ingredient tied increased risk of cancer | TheHill

Chantix was approved by the FDA in 2006.

Drug Approval Package: Chantix (Varenicline) NDA #021928 (fda.gov)

A mere 14 years later, they're recalling it due to the fact that it causes cancer.

Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content | FDA

Remember, the benefits outweigh the risk! (but we're still recalling it...)

In the past five years I've seen more drugs recalled that were considered "safe" from than I can recall of any other time in history.

It's why long term testing is vital to the safety of a product.

I don't fault the FDA, they certainly use whatever knowledge they have at the time.

It's why I don't understand why so many people are certain that the vaccine, which is entirely new and never been used before now, are so certain that it's safe. Even if you're relatively safe after one vaccination....can we be certain that 5 years from now and 10 vaccinations later, there won't be serious consequences?

 

[Ana the Ist]

It was pretty easy to spot that this was always going to be an anti-vax agenda post. However people take two doses of the vaccine. That's it.

It bears little resemblance to a drug that is taken at regular intervals over many months.

Plus, if Pfizer, the FDA and 'big pharma" are all involved in some conspiracy, then why did they volunteer to recall at all?

That's it?

Surely you're aware that the vaccine loses efficacy over time....and that 6 months later, it's not nearly as effective as a traditional vaccine.

You're looking at booster shots arguably for the rest of your life if you're going the "vaccine route".

 

[rambot]

Just for rationality and facts, people keep telling us that the vaccines have been so thoroughly tested that there's no way there's any unknown side effects. Yet it took Chantrix 12 years of being fully on the market to identify the cancer-causing side effects, and another 3 years for them to pull the plug on it. It was causing cancer for 12 years before they even knew (or admitted to knowing) it was doing it.

This is exactly why FDA approval is meaningless.

The BEST solutions is to never take drugs I guess? IF we're going to be reductionist about it. BEacuse this ONE medication (really? I'm sure there's more)


But yes. TOTALLY meaningless. The FDA should be COMPLETELY disband because of this event. Clearly their approval means ABSOLUTELY nothing because of something they could have never predicted to begin with.

Certainly they have never done ANYTHING to help united states citizen stay safe. No.
No. Nothing. Ever

They DEFINITELY should not exist. Frankly, we should be just trusting the companies that make the drugs.

Or...no wait.

We should be trusting our gut and the internet.