Health Canada issues two recalls for Pfizer blood pressure drugs over impurity
Last year, Pfizer stopped distribution of megablockbuster smoking cessation drug Chantix over an increased level of carcinogenic nitrosamines.
Now, two of the Big Pharma’s blood pressure drugs have been recalled in Canada this week after Canada’s health authority found levels of a type of nitrosamine too high to be allowed in the drugs.
Pfizer Canada recalled all 8 lots of blood pressure drug Accuretic yesterday after higher-than-approved levels of N-nitroso-quinapril were found. That recall was just two days after the pharma subsidiary recalled 15 lots of Inderal-LA, another blood pressure drug, over similar concerns over nitrosamines.
The regulator said in recall notices for the two drugs that there’s no immediate risk in taking Pfizer’s meds, at least temporarily. The agency advised, “there is no immediate risk in continuing to temporarily take the recalled Accuretic medication since the potential risk of cancer is with long-term exposure (every day for 70 years) to the nitrosamine impurity above the acceptable level.”
However, patients on those drugs should talk to a doctor about treatment alternatives, according to Health Canada.
“Continue taking your medication unless you have been advised to stop by your health care provider. Not treating your condition poses a greater health risk,” the regulator added.
Pfizer Canada kept it simple — saying in a statement to Endpoints News, “In response to requests from various regulatory authorities, manufacturers across the pharmaceutical industry have been evaluating the potential for the presence or formation of certain impurities, called nitrosamines, in pharmaceutical products. There is no immediate risk to patients taking this medication.”
7 of the 8 lots that were recalled for Accuretic are expiring in July, with the last one expiring sometime next year. For Inderal-LA, all but two of the lots of drugs expire in 2023 and 2024.
Pfizer halted distribution of its anti-smoking med Chantix, recalling four lots of the drug last June — a year after the FDA found high levels of the nitrosamine NDMA in the generic diabetes drug metformin. That began a multi-month saga when the FDA said it would still allow certain manufacturers to distribute batches of the drug that have more than the usual nitrosamine levels, so long as the impurity remains under the interim acceptable limit.