CHAMPIX (varenicline) — Potential Risk Posed by Long-Term Exposure to Nitrosamine Impurity, N-nitrosovarenicline, Exceeding Acceptable Intake Limit

Starting date:
June 30, 2021
Posting date:
June 30, 2021
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information, Product Safety, New safety information
Audience:
Healthcare Professionals
Identification number:
RA-75961

Last updated:

Audience

Healthcare professionals including community pharmacists.

Key messages

  • Testing results received from Pfizer Canada ULC identified 5 lots of CHAMPIX (varenicline) with levels of a nitrosamine impurity, N-nitrosovarenicline, above the acceptable intake limit established by Health Canada. As a result, Health Canada requested that Pfizer Canada ULC recall the 5 impacted lots.
  • N-nitrosovarenicline has been shown to cause gene mutations in an in vitro study, indicating that its presence in CHAMPIX may be associated with a potential increased cancer risk in humans. There is no immediate risk to patients taking this medication as an increased cancer risk would be associated with long-term use.
  • Healthcare professionals are advised to:
    • Not dispense these 5 lots of CHAMPIX (see Products affected section) due to the potential safety risk posed by long-term exposure to this impurity.
    • Remove all units of these 5 lots from the inventory.
    • Consider using available alternative products on the market.
    • Contact the company directly if you have questions regarding product return or disposal.
    • Inform patients to continue to take their medication as prescribed by their healthcare professional.
  • Health Canada continues to assess information on this issue and is monitoring this situation closely.

   

Issue

Testing results received from Pfizer Canada ULC identified 5 lots of CHAMPIX with levels of a nitrosamine impurity, N-nitrosovarenicline, above the acceptable intake limit established by Health Canada. N-nitrosovarenicline has been shown to cause gene mutations in an in vitro study, indicating that its presence in CHAMPIX may be associated with a potential increased cancer risk in humans. Health Canada is informing healthcare professionals about the risk associated with these 5 lots.

Products affected

CHAMPIX (varenicline), Pfizer Canada ULC
Strength/Dosage Form DIN Lot # Expiry Date Recall Status
0.5 mg and 1 mg Tablet, Kit 02298309 00019062 2021-08 Recalled
00020452 2021-12 Recalled
00020451 2022-01 Recalled
0.5 mg Tablet 02291177 ED7397 2022-05 Recalled
1 mg Tablet 02291185 00020013 2021-12 Outstanding


Background Information

CHAMPIX is a prescription medication indicated for smoking-cessation treatment in adults, in conjunction with smoking-cessation counselling.

N-nitrosovarenicline, a nitrosamine impurity, has been shown to cause gene mutations in an in vitro study, indicating that its presence in CHAMPIX may be associated with a potential increased cancer risk in humans. However, studies have not been conducted to determine whether exposure to N-nitrosovarenicline leads to the development of cancer in animals or humans. Some nitrosamine impurities are probable human carcinogens. This means that long-term exposure to a level above what is considered safe could increase the risk of cancer. Health Canada established an acceptable intake limit based on available scientific data.

On October 26, 2020, Health Canada requested all companies marketing varenicline to evaluate the risk of the presence of nitrosamine impurities in their drug product and to conduct testing as necessary.

Testing results received from Pfizer Canada ULC identified 5 lots of CHAMPIX with levels of a nitrosamine impurity, N-nitrosovarenicline, above the acceptable intake limit established by Health Canada. As a result, Health Canada requested that Pfizer Canada ULC recall the 5 impacted lots to address this safety risk (see Products affected section). CHAMPIX is not considered a medically necessary drug product in Canada, as there are alternative varenicline products on the market.

Health Canada has taken action to address the issue of nitrosamine impurities found in certain medications since the summer of 2018. Health Canada continues to work closely with international regulatory partners and companies to address the issue and will continue to keep Canadians informed. More information on Health Canada's work to address nitrosamines in medications is available on Canada.ca.

Who is affected

Information for consumers

Health Canada is advising that there is no immediate risk to patients taking this medication. Patients should continue to take their medication as prescribed by their healthcare providers. Patients do not need to return their medication to their pharmacy. Contact your healthcare provider if you are taking the impacted product and you have concerns about your health.

Information for healthcare professionals

Healthcare professionals are advised to:

  • Not dispense these 5 lots of CHAMPIX (see Products affected section) due to the potential safety risk posed by long-term exposure to this impurity.
  • Remove all units of these 5 lots from the inventory.
  • Consider using available alternative products on the market.
  • Contact the company directly if you have questions regarding product return or disposal.
  • Inform patients to continue to take their medication as prescribed by their healthcare professional.

Action taken by Health Canada

Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system as well as social media channels including LinkedIn and Twitter.

Health Canada continues to assess information on this issue and is monitoring this situation closely.

Report health or safety concerns

Health Canada’s ability to monitor the safety of marketed health products depends on healthcare professionals and consumers reporting adverse reactions and medical device incidents. Any serious or unexpected side effects in patients receiving CHAMPIX should be reported to Health Canada.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For questions related to management of compliance and enforcement activities for health products including human and veterinary drugs and natural health products in Canada, contact Health Canada at:

Health Product Compliance & Enforcement Unit
E-mail: hc.hpce-cpsal.sc@canada.ca