The Canadian branch of the pharmaceutical company Pfizer is recalling all of its lots of propranolol hydrochloride extended-release capsules, called Inderal-LA, due to the presence of a nitrosamine impurity above the acceptable value.
Posted at 7:10 p.m.
Long-term exposure to nitrosamine, the molecule N-nitroso-propranolol, at a concentration above what is considered safe may increase the risk of cancer.
All humans are exposed to nitrosamine through food, water, and air pollution. In acceptable concentrations, there would be no health risk, including taking a drug containing an impurity at or below the acceptable concentration every day for 70 years.
As with previous recalls due to nitrosamine impurities, Health Canada is of the opinion that there is no immediate concern with continuing to take Inderal-LA, since the risk of cancer is associated with exposure to long term at concentrations of nitrosamine impurities above the acceptable value. Failure to treat a disease presents a greater health hazard.
Inderal-LA is a beta-blocker class prescription medication used in adults to treat high blood pressure and prevent angina.
Patients can continue to take the medication as prescribed and do not need to return it to their pharmacy, but should contact their healthcare professional to discuss other treatment options.
No other company markets extended-release propranolol in Canada, however immediate-release propranolol products are available along with other treatment options and other beta-blockers.
All lots of the product are being recalled in strengths of 60 mg, 80 mg, 120 mg and 160 mg.