(WTAJ) — Pfizer has recalled nine lots of varenicline, sold under the brand name Chantix, and is pausing any more releases into the U.S. market, the FDA announced Friday.
According to the recall, the medication for trying to stop smoking might have too much N-nitroso-varenicline, classified as a “probable human carcinogen.”
The FDA stated that there is no immediate risk to patients taking this medication. An increased cancer risk would be associated with long-term use, and the health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.
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WHAT IS N-NITROSO-VARENICLINE:
N-Nitroso-varenicline belongs to the nitrosamine class of compounds, some of which are classified as probable or possible human carcinogens (substances that could cause cancer), based on laboratory tests such as rodent carcinogenicity studies. Although there are no data available to directly evaluate the carcinogenic potential of N-nitroso-varenicline, information available on closely related nitrosamine compounds was used to calculate lifetime exposure limits.
Pfizer is recalling the varenicline lots currently stored in warehouses. FDA recommended Pfizer revise its recall to the consumer level in order to take into account the product currently on the market, but the company has not yet done so.
In addition to the voluntary recall, Pfizer is holding the release of varenicline to the U.S. market until it can confirm N-nitroso-varenicline levels below what the company considers to be acceptable.
WHAT PATIENTS SHOULD KNOW:
- Continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option.
- Contact your health care professional if you are taking this medication and have questions about your health.
What health care professionals should know:
- FDA has determined the recalled varenicline poses an unnecessary risk to patients. Therefore, FDA recommends health care professionals consider other available treatment options for the patient’s medical condition.
- If you have varenicline samples from this company, quarantine them, and do not provide them to patients.
- Contact Pfizer directly if you have questions regarding product return or disposal.
FDA is actively considering options to help mitigate a shortage of varenicline in the U.S. including working to identify an alternate supplier. The agency is continuing to investigate the presence of N-nitroso-varenicline in varenicline products and will provide more information as it becomes available.
Today, we have better testing methods than ever before, and we have a better understanding of what to look for in products’ chemical structure and manufacturing processes that may increase the risk of forming low levels of impurities. Improved technology enables us to detect even trace amounts of impurities in drug products and may be the reason why more products have been recently found to have detectable levels of nitrosamines.
Patients and health care professionals should report any adverse reactions with varenicline to FDA’s MedWatch program to help the agency better understand the scope of the problem.
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