Pfizer Recalls Two Blood Pressure Medications Within a Week Due to Carcinogenic Nitrosamine Impurities

Compiled by Fan Dongdong

Currently, Pfizer is conducting a full market recall in Canada of the blood pressure control drug Accuretic. This recall is due to the detection of potentially carcinogenic impurities called nitrosamines in the drug, with levels exceeding the acceptable safety threshold.

Accuretic is a prescription medication for controlling blood pressure, combining quinapril hydrochloride and chlorthalidone. Health Canada stated that the recall covers a total of 8 batches of Accuretic products in various dosages, including 10/12.5 mg, 20/12.5 mg, and 20/25 mg.

Canadian regulators stated that the temporary use of the recalled batches of Accuretic may not pose an immediate risk, but long-term exposure to this type of impurity could lead to serious health issues. Therefore, the agency recommends that patients affected by this recall actively seek alternative medications. Stopping the medication on their own may delay the patient's treatment, potentially leading to greater health risks.

Currently, patients who have already been taking the drug can continue to take it as prescribed by their healthcare provider without returning it to the pharmacy. However, patients should promptly contact relevant personnel to discuss alternative treatment options to Accuretic. Notably, just a few days ago, Pfizer Canada similarly announced a recall of its blood pressure medication Inderal in 60 mg, 80 mg, 120 mg, and 160 mg dosages due to the presence of nitrosamine impurities that are potentially carcinogenic.

Lower levels of nitrosamine impurities are basically harmless to the human body, as this substance is abundant in various foods, drinking water, and air. However, long-term exposure to high levels may potentially lead to cancer. Health Canada defines the carcinogenic potency of these impurities as daily exposure over a span of 70 years.

Since the summer of 2018, Health Canada has been working to verify the issue of nitrosamine impurities in drugs. The agency had requested that major pharmaceutical companies complete detailed assessments of their manufacturing processes and required safety testing for potential nitrosamine impurities in their products. Health Canada stated that as this safety effort progresses, further recalls of other products may occur in the future.

In the past few years, due to the presence of nitrosamine impurities N-nitrosodimethylamine in medications, several pharmaceutical manufacturers have had to recall the blood pressure drug valsartan and the diabetes drug metformin. In September 2021, Pfizer also announced a recall of all batches of 0.5 mg and 1 mg doses of Chantix for the same reason. Chantix is a medication used to help smokers quit, and the recall was due to the detection of the carcinogenic impurity N-nitroso-varenicline in the drug.

Reference Source:

1、Pfizer Canada recalls blood pressure drug on potential cancer-causing impurity

2、Pfizer recalls 2nd blood pressure med in a week, again on potential carcinogen fears