Pfizer Canada has recalled lots of blood pressure drug Accuretic because of the presence of higher-than-allowed levels of a type of nitrosamine called N-nitroso-quinapril.
The recall covers eight Accuretic batches across 10/12.5-mg, 20/12.5-mg and 20/25-mg strengths, Health Canada said.
The product pull comes just three days after Pfizer Canada said it was recalling 15 lots of another blood pressure drug, Inderal, on similar nitrosamine impurity concerns.
The pharmaceutical giant said it was recalling six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets because of the presence of nitrosamine.
“Pfizer believes the benefit/risk profile of the products remains positive based on currently available data,” the company said in a news release. “Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication.”
The company noted that everyone is exposed to nitrosamines. They are common in water and foods, including cured and grilled meats, dairy products and vegetables. Exposure to above acceptable levels over a prolonged period can increase the risk of cancer, the company said.
The company urged patients taking the products to consult theirs doctors for alternative treatment options.
“Not treating your condition may pose a greater health risk,” the regulator added.
ll but one of the Accuretic lots in question were set to expire in July. Lot FM9526, meanwhile, was meant to be good until the end of August 2023.
All three product strengths covered in the recall are in short supply, according to Drug Shortages Canada.
The recall earlier this week of Inderal covered four dosing strengths, which are also in short supply in Canada.
Health Canada has been working to get a handle on the nitrosamine impurity situation since the summer of 2018. It’s directed companies to complete detailed evaluations of their manufacturing processes and test products if their reviews pinpoint potential nitrosamine formation.
“As this work progresses, additional products may be identified and recalled as appropriate,” Health Canada added.
Over the past few years, myriad drugmakers have had to recall valsartan blood pressure meds and metformin diabetes drugs over the presence of another type of nitrosamine called N-Nitrosodimethylamine.
Excess levels of nitrosamines were also responsible for last year’s Chantix recall. Pfizer halted global distribution of the smoking cessation med in June. By September, the company was recalling all batches of the drug at the 0.5-mg and 1-mg doses in the U.S.
