{"id":36854,"date":"2021-07-09T16:38:23","date_gmt":"2021-07-09T20:38:23","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=36854"},"modified":"2023-11-07T09:29:28","modified_gmt":"2023-11-07T14:29:28","slug":"chantix-recall","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/chantix-recall\/","title":{"rendered":"Pfizer issues voluntary recall of Chantix"},"content":{"rendered":"

In July 2021, Pfizer announced a voluntary recall of nine lots of <\/span>Chantix (varenicline)<\/span><\/a>, its smoking cessation drug, due to concern about levels of nitrosamine in this medication. Nitrosamines are a type of<\/span> impurity<\/span><\/a> that can exist in pharmaceutical products and are considered possible carcinogens when they are above acceptable levels.\u00a0<\/span><\/p>\n

Varenicline<\/span><\/a>, the first generic version of Chantix, was <\/span>approved by the U.S. Food and Drug Administration<\/span><\/a> on August 11, 2021, one month after Pfizer\u2019s initial recall. In September 2021, <\/span>Pfizer expanded the recall<\/span><\/a> to <\/span>all<\/span><\/i> lots of 0.5 mg and 1 mg tablets of Chantix. Currently, Chantix is not available as a brand-name drug (Pfizer still has production paused) and only varenicline is available as the generic.<\/span><\/p>\n

Why was Chantix recalled?<\/span><\/h2>\n

You\u2019ve been exposed to nitrosamines many times and probably didn\u2019t even know it. That\u2019s because these compounds are common in water and foods, including cured and grilled meats, dairy products and vegetables, according to the FDA. At low levels, experts don\u2019t believe they\u2019re harmful.\u00a0\u00a0<\/span><\/p>\n

However, nitrosamine impurities could potentially increase your cancer risk if you consume enough over an extended period of time. As such, the FDA set limits for the daily intake of nitrosamines. Nitrosamine impurities have led to the recall of other medications, such as <\/span>Zantac (ranitidine)<\/span><\/a> and <\/span>metformin ER<\/span><\/a>.<\/span><\/p>\n

After previous recalls, the FDA created <\/span>guidance for pharmaceutical manufacturers<\/span><\/a> to detect and prevent higher-than-recommended nitrosamine levels. As part of the suggested investigation, Pfizer discovered levels of the impurity known as N-nitroso-varenicline that exceeded the acceptable intake limit in Chantix. That prompted Pfizer\u2019s decision to voluntarily recall certain lots of this particular drug.<\/span><\/p>\n

\u201cThe <\/span>benefits<\/span><\/a> of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime,\u201d Pfizer spokesperson Steven Danehy said in an email, according to <\/span>Reuters<\/span><\/a>.<\/span><\/p>\n

RELATED: <\/b>What to do if a drug is recalled<\/b><\/a><\/p>\n

What to take instead of Chantix<\/span><\/h2>\n

The generic varenicline is available in doses of 0.5 mg (white pill) and 1.0 mg (blue pill) for use as an aid in smoking cessation treatment. It works by <\/span>blocking<\/span><\/a> the pleasant effects of nicotine on the brain.\u00a0<\/span><\/p>\n

There are three ways to take varenicline, and a healthcare professional will help you determine the best method before beginning the medication.<\/span><\/p>\n