Fact Check: Did Pfizer withdraw the drug Chantix for causing Cancer?

Quick Take

Social media posts claim that Pfizer has withdrawn the drug Chantix because it was causing Cancer. We fact-checked and found that the claim is half true.

The Claim

“FDA approval in 2006. Recalled in 2021 for causing Cancer,” reads a Facebook post that shows a bottle of the medicine Chantix. Such posts can be seen here and here and a screenshot is given below.

Fact Check

Did Pfizer withdraw Chantix from market recently?

Yes. Pfizer had recalled the smoking cessation drug Chantix from market in September 2021.

As per the company announcement published on the website of US FDA, the recall was a voluntary action by the company. “Wholesalers and Distributors with an existing inventory of Chantix tablets, should stop use and distribution and quarantine the product immediately,” reads the circular dated September 16, 2021.

Was Chantix withdrawn because it was causing Cancer?

No. There is no evidence that Chantix was causing Cancer. No particular report was published or referred anywhere in the social media posts that claim that Chantix has caused Cancer.

However, recent laboratory testing reports revealed that Chantix contains contain nitrosamine, a potentially carcinogenic (Cancer causing agent).

The company circular about recalling Chantix also reveals the same. “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,” reads the circular.

FDA recognizes nitrosamine as an impurity in drug manufacturing process and has a guideline for the same. The authority body also mentions, “nitrosamine impurities have been found in only some drug products, and batches of those products have been recalled when there were unacceptable levels.”

It also needs to be understood that Chantix is the the first or the only drug that has been recalled due to nitrosamine impurities. In October 2021, Lupin Pharmaceuticals voluntarily recalled all lots of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets due to the presence of N-nitroso-irbesartan.

The claim that Chantix caused Cancer and hence was recalled has no evidence.

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