Pfizer recalls blood pressure control drug twice in a week due to nitrosamine carcinogenic impurity

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Pfizer recalls blood pressure control drug twice in a week due to nitrosamine carcinogenic impurity

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Pfizer recalls blood pressure control drug twice in a week due to nitrosamine carcinogenic impurity

Pfizer is currently recalling blood pressure control drug Accuretic from the Canadian market after it was found to contain the potentially carcinogenic impurity nitrosamines at levels above acceptable safe levels.

Accuretic is a prescription drug for blood pressure control that is a combination therapy of quinapril hydrochloride and chlorothiazide. Health Canada said the recall covers a total of eight batches of Accuretic products in multiple doses, including 10/12.5 mg, 20/12.5 mg and 20/25 mg.

The Canadian regulator said that the temporary use of the recalled batch of Accuretic may not pose a direct risk, but if long-term exposure to such impurities could cause serious health problems, the agency advised patients affected by the recall to actively Seeking alternative medicines and stopping them on their own may delay the patient’s condition, which in turn can lead to greater health impacts.

Currently, patients already taking the drug can continue to take the treatment as prescribed by their healthcare provider without returning the drug to the pharmacy, but patients should promptly contact their responsible person to discuss treatment options other than Accuretic.

It is worth noting that just a few days ago, Pfizer Canada also announced the recall of 60 mg, 80 mg, 120 mg and 160 mg of blood pressure drug Inderal because of similar carcinogenic impurities of nitrosamines.

Low levels of nitrosamine impurities are basically harmless to the human body, and this substance exists in large quantities in various foods, drinking water and air. However, long-term, high-level exposure can cause cancer, and Health Canada defines the carcinogenic intensity of this impurity as daily and 70 years of continuous exposure.

Health Canada has been working to verify nitrosamine impurities in pharmaceutical products since the summer of 2018, when the agency asked major pharmaceutical companies to complete detailed assessments of their manufacturing processes and required investigations for potential nitrosamine impurities in products.

 Health Canada said further recalls of other products may be possible in the future as this safety work progresses.

Over the past few years, several drugmakers have had to recall blood pressure drug valsartan and diabetes drug metformin because of the nitrosamine impurity N-nitrosodimethylamine mixed in their medicines.

In September 2021, Pfizer also announced the recall of all batches of 0.5 mg and 1 mg doses of Chantix for the same reason. Chantix, a drug used to help smokers quit smoking, was recalled after it was found to contain the carcinogenic impurity N-nitroso-varenicline.

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

(source:internet, reference only)

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