Add another country to the recall list for Pfizer’s blood pressure medicines.
Monday, the company pulled (PDF) one lot of Accuretic off shelves in the U.K., continuing its busy month of voluntary recalls as a precautionary measure because of the presence of cancer-causing agents.
Earlier this month in Canada, Pfizer issued two rounds of recalls for Accuretic and another for blood pressure medicine Inderal. Then last week in the U.S. and Puerto Rico, Pfizer pulled back Accuretic and its two generic versions produced by Greenstone.
The initiative in Canada included 23 batches of the blood pressure meds. In the U.S. and Puerto Rice, the move covered 11 lots.
The most recent recall in England is for tablets that were first distributed in April 2020 and are set to expire Oct. 30. Pharmacies and wholesalers are asked to quarantine and return any available stock from the batch.
There is no immediate risk to patients who are taking Accuretic, Pfizer said (PDF). Users are advised to continue treatment with Accuretic because the danger posed by suddenly halting blood pressure medication exceeds the risk presented by the impurity. Patients also are advised to consult their doctor to determine an alternative treatment.
All of these recalls—in addition to several rounds last summer of Pfizer’s smoking-cessation drug Chantix—were triggered because of high levels of nitrosamines. The impurities are commonly found in the air, drinking water, dairy products, vegetables and cured and grilled meats and “may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” Pfizer said in its statement.
The FDA writes that someone taking a drug that contains an acceptable level of nitrosamines could do so every day for 70 years and is “not expected to have an increased risk of cancer.”
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. The nitrosamine type in Pfizer’s recent recalls is dubbed N-nitroso-quinapril.