- Pfizer has recalled its smoking cessation drug Chantix due to concerns over a potential cancer-causing ingredient.
- Experts say people taking Chantix should continue using the medication until they can talk with their doctor about potential alternatives.
- They also note that the health risks from smoking outweigh the concerns over Chantix.
Pfizer is recalling its anti-smoking drug Chantix after the Food and Drug Administration (FDA)
FDA officials did add that there is no immediate risk to people taking Chantix and that people using the drug “should continue taking the current medicine until their pharmacist provides a replacement or their doctor prescribes a different treatment.”
The FDA approved the prescription medication in 2006 to help adults quit smoking. It’s typically used for 12 to 24 weeks.
The FDA also pointed out the benefits of quitting smoking still outweigh any cancer risk from taking Chantix.
The concerns over Chantix center on nitrosamine, a chemical found in tobacco, tobacco smoke, and foods such as fish, fried food, meat, and beer. Some nitrosamines have been found to cause cancer in laboratory animals.
Nitrosamines have no known industrial use. They’re often produced as unintentional byproducts of food processing and preparation.
“Nitrosamines are impurities that are common in water and in foods, including cured and grilled meats, dairy products, and vegetables,” Julie Suko, PharmD, a vice president at drug database provider First Databank, told Healthline. “Everyone is exposed to some level of nitrosamines.”
Alhough Chantix hit the market in 2006, nitrosamines only became an issue earlier this year when Pfizer paused distribution of Chantix in June.
Further testing led the company to start recalling certain lots of the drug. The recall expanded in August.
“The FDA has stated that better testing methods and a knowledge of what to look for in the chemical structures of drug products and manufacturing processes has enabled them to identify the increased risks of forming low levels of nitrosamines,” Suko said.
“Improved technology has enabled the detection of trace amounts of impurities in drug products and may be the reason why more products have been found to have low levels of nitrosamines. The FDA has stated that as investigations and testing continue, low levels of nitrosamines may be found in additional drugs,” said Suko.
Suko noted the FDA has told manufacturers to keep up with current technology.
“Manufacturers are also responsible for developing and using suitable methods to detect and limit unacceptable impurities, including any new impurities that may occur when manufacturing processes are changed,” she said.
Dr. Puja Uppal is the founder and chief medical officer of the health information website Think Healthy Doctor.
She told Healthline that even though Chantix is sometimes prescribed for as long as 9 months, it’s still not usually long enough to seriously increase a person’s chance of getting cancer.
There are other options for people who want to avoid the drug.
“People still have many smoking cessation options besides Pfizer’s Chantix,” Uppal said. “So, I wouldn’t say this whole voluntary recall should dissuade anyone from smoking cessation. People should still be encouraged to quit smoking and their journey should still be applauded.”
Uppal said Chantix users can get the generic form of the drug, which the FDA approved in August.
“Also, the FDA is allowing Chantix from Canada to be sold in the U.S. for the time being,” she said.
“Apart from Chantix manufactured in Canada and the generic form of Chantix, people can consider Zyban or its generic version, which are both FDA approved to help people quit smoking. Then there’s the whole family of nicotine-containing products such as gum, patches, and lozenges,” Uppal said.
Suko said people taking smoking cessation drugs who are concerned about nitrosamine should talk with their doctor.
“Patients taking prescription medications with potential nitrosamine impurities should not stop taking their medications,” Suko said. “Patients taking over-the-counter medications with potential nitrosamine impurities may consider using other OTC products approved for their condition.”