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Pfizer pulls blood pressure med in Canada on carcinogen fears

Pfizer is pulling 15 lots of its long-acting blood pressure med Inderal from Canadian shelves, citing unacceptable nitrosamine levels across a range of product strengths.

The recall specifically covers multiple batches of 60-mg, 80-mg, 120-mg and 160-mg extended-release capsules, the Canadian government said in a recall notice published this week.

Inderal-LA is a prescription medication known as a beta-blocker. It is used in adults to treat high blood pressure and prevent angina pectoris (a condition associated with sharp chest pain and difficulty breathing, often associated with exercise).

The suspect Inderal batches were set to expire as early as Sept. 30, 2022, and as late as Jan. 31, 2024. The beta blocker Inderal, also known as propranolol hydrochloride, is used to treat high blood pressure and prevent angina pectoris—a condition associated with sharp chest pain and breathing trouble.

All four Inderal strengths covered in the recall are currently in shortage in the great white north, according to Drug Shortages Canada. Health Canada has told patients they can continue to take Inderal as prescribed and don’t need to return the medication, though they should consult with a doctor on other treatment options.

There’s no “immediate risk” in continuing to take the recalled drugs because nitrosamines only have the potential to cause cancer after long-term exposure, the Canadian regulator noted. Nitrosamines are common in daily life, including in smoked and cured meats, dairy products, vegetables, drinking water and even in the air, Health Canada added, the regulator said:.

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 for the nation’s Inderal shortage, Pfizer is the only company that markets the drug in an extended-release format in Canada. That said, immediate-release propranolol remains on tap, alongside other treatment options and beta blockers, Health Canada said.

As previously reported, Pfizer in June halted global distribution of the smoking cessation med after finding unacceptable levels of nitrosamines in certain lots.


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