These guidelines also have cut-off limits for each specific nitrosamine. The FDA has a set of guidelines that all pharmaceutical manufacturers must follow regarding how and when to test their medications for nitrosamine impurities. How does the FDA regulate nitrosamine levels in medications? Nothing is known about whether N-nitroso-varenicline is harmful, but Pfizer is treating it like other nitrosamines when it comes to its presence in medications. The nitrosamine found in Chantix is called N-nitroso-varenicline, and it’s unique from the more well-known N-nitrosodimethylamine (NDMA) found in ranitidine and several other medications. Currently, there is no evidence to say if nitrosamines are harmful in humans or not. There are reports that when nitrosamine is given to rats, it can cause tumors to grow in multiple organs, including the liver, kidneys, pancreas, bladder, and lungs. This link is still being investigated in humans, but animal studies suggest nitrosamines are carcinogenic (cancer-causing). When large amounts of nitrosamines are consumed for long periods of time, they may raise your risk of cancer. The problem isn’t the chemical itself, but rather how much was found in certain medications. We’re all exposed to nitrosamines to some degree, and our bodies even make them while digesting certain foods. Nitrosamines are chemical by-products found in multiple natural sources and foods, such as cured meats, dairy products, and vegetables. What are nitrosamines, and why are they bad for you? Be sure to check the FDA’s MedWatch page for details on the latest medication and medical device recalls. While these options may still contain nitrosamines, their levels are within acceptable FDA limits.īecause this is a developing situation, this information could change over the coming months.

In August, the FDA also approved a generic varenicline to be produced in the U.S. To help alleviate the medication shortage this recall could cause, the FDA is currently allowing distributors to import varenicline (generic Chantix) from Canada. Pfizer has voluntarily recalled all batches of the medication.

The FDA didn’t initiate the recall of Chantix. While there have been no reports of people being harmed by the nitrosamines in Chantix, Pfizer halted its production to be extra cautious. Pfizer hasn’t stated how long they will pause the production, but more testing needs to be done before it can be sent to pharmacies again. Because of this, Pfizer stopped producing the medication. The amount of the contaminant present was higher than what’s acceptable according to FDA guidelines. Why did Pfizer stop producing Chantix?Īs part of regular safety monitoring, Pfizer discovered the presence of a nitrosamine in batches of Chantix during production. Here, we’ll discuss the details of Chantix’s halt and what to know if you are currently taking the medication. But why is this happening, and is it safe to keep taking Chantix? Ranitidine (Zantac), metformin, and losartan have all run into similar problems over the past few years. This isn’t the first time a medication has been pulled due to the presence of nitrosamines. In the days that followed this announcement, this pause in production turned into a voluntary recall. The halt of this smoking cessation pill is due to a discovery of higher levels of nitrosamines - possible carcinogens - in Chantix than what’s considered acceptable. Thanks in advance.At the end of June 2021, pharmaceutical manufacturer Pfizer announced they are stopping the global production of Chantix (varenicline). Any advice? I would really appreciate any and all suggestions, others experience and knowledge or thoughts regarding this. I would really like to begin using Chantix if possible, just have some concerns. I haven't started taking Chantix just yet, I'm trying to gather more information.

I plan on checking with my psychiatrist about all of this as well, just thought I'd ask about it in the meantime. One, will taking Chantix worsen the bipolar disorder? And two, can I really also use nicotine lozenges as well as using Chantix? I've done a lot of research regarding all of this, but the information is confusing and conflicting. She also told me that I could also use nicotine lozenges in addition to taking Chantix. I have bipolar 1 disorder and my primary care physician said that this was safe for me to take to help me quit smoking. I'm currently smoking between 10-20 cigarettes a day. I'm now 40 years old and have been smoking cigarettes again since last September. I previously smoked cigarettes, a pack a day, from age 18-32, then quit using nicotine lozenges.

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