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FDA alerts health professionals about varenicline recall

After Pfizer announced in late June that it was halting worldwide distribution of varenicline (Chantix) after detecting elevated levels of nitrosamines in the drug, FDA came out to alert patients and health professionals about the voluntary recall.

“[Pfizer] is recalling varenicline because it may contain levels of a nitrosamine impurity, called N-nitroso-varenicline, above FDA’s acceptable intake limit. N-nitroso-varenicline may be associated with a potential increased cancer risk in humans, but 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,” said FDA in a news release.

While Pfizer is only recalling varenicline lots currently stored in warehouses, FDA recommended that Pfizer revise its recall to the consumer level in order to take into account the products currently on the market.

According to FDA:

Patients should:

  • -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.

Health care professionals should:

  • -Consider other available treatment options for the patient’s medical condition since FDA has determined that recalled varenicline poses an unnecessary risk to patients.
  • -Quarantine varenicline samples from this company if you have them and do not provide them to patients.
  • -Contact Pfizer directly if you have questions regarding product return or disposal.

FDA said it is actively considering options to help mitigate a shortage of varenicline in the United States, 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.

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