Advisory - Pfizer recalls Accuretic blood pressure tablets due to a nitrosamine impurity

OTTAWA, ON, March 3, 2022 /CNW/ -

Summary

  • Products: Accuretic (quinapril hydrochloride and hydrochlorothiazide)
  • Issue: All lots are being recalled due to the presence of a nitrosamine impurity above the acceptable level for long-term use.
  • What to do: Continue taking your medication unless you have been advised to stop by your health care provider. Not treating your condition may pose a greater health risk. Contact your health care provider to discuss other treatment options.

Issue
Pfizer Canada ULC is recalling all lots of Accuretic (quinapril hydrochloride and hydrochlorothiazide) medication in 10/12.5 mg, 20/12.5 mg and 20/25 mg strengths due to the presence of a nitrosamine impurity (N-nitroso-quinapril) above the acceptable level.

Accuretic is a prescription drug used to treat high blood pressure. It contains a combination of quinapril hydrochloride and hydrochlorothiazide, which both lower blood pressure.

Long-term exposure to N-nitroso-quinapril at a level above what is considered acceptable may increase the risk of cancer. We are all exposed to low levels of nitrosamines through a variety of foods (such as smoked and cured meats, dairy products and vegetables), drinking water and air pollution. This impurity is not expected to cause harm when ingested at or below the acceptable level. A person taking a drug that contains this impurity at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer.

As with previous recalls involving nitrosamine impurities, Health Canada is advising that there is no immediate risk in continuing to temporarily take the recalled Accuretic medication since the potential risk of cancer is with long-term exposure (every day for 70 years) to the nitrosamine impurity above the acceptable level. Patients can continue to take their medication as prescribed by their health care provider and do not need to return their medication to their pharmacy, but they should contact their health care provider to discuss other treatment options.

Health Canada is monitoring the effectiveness of the recall and the company's implementation of any necessary corrective and preventative actions. Should any additional recalls be deemed necessary, Health Canada will update the table and inform Canadians.

Affected products

Product

DIN

Lot

Expiry

Accuretic 10/12.5mg

02237367

FM9526

2023-08-31

Accuretic 10/12.5mg

02237367

FA3736

2022-07-31

Accuretic 10/12.5mg

02237367

EJ5192

2022-07-31

Accuretic 20/12.5mg

02237368

EX4411

2022-07-31

Accuretic 20/12.5mg

02237368

ET9511

2022-07-31

Accuretic 20/12.5mg

02237368

EF3087

2022-07-31

Accuretic 20/25mg

02237369

FA9224

2022-07-31

Accuretic 20/25mg

02237369

EA0781

2022-07-31

What you should do

  • Continue taking your medication unless you have been advised to stop by your health care provider. Not treating your condition may pose a greater health risk.
  • Contact your health care provider to discuss other treatment options. There is currently a reduced supply of combination quinapril hydrochloride and hydrochlorothiazide nationally; however, other drug products are available for treating high blood pressure.
  • If you have questions about the recall, contact Pfizer Canada ULC at 1-800-463-6001 or www.pfizermedinfo.ca for medical inquiries, and at 1-800-387-4974 for general inquiries.
  • Report any health product-related side effects or complaints to Health Canada.

Background
Health Canada has been working to address the issue of nitrosamine impurities found in certain medications since the summer of 2018. Companies were directed to complete detailed evaluations of their manufacturing processes and are testing products if their reviews identified a potential for nitrosamine formation. As this work progresses, additional products may be identified and recalled as appropriate. 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.

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SOURCE Health Canada

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