Pfizer is recalling certain lots of a popular blood pressure drug nationwide as well as two authorized generics distributed directly to patients by a subsidiary because of higher-than-acceptable levels of a nitrosamine linked to potential cancer risk.
The drug manufacturer said Monday that it was pulling six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCI/hydrochlorothiazide tablets -- all hypertension treatments -- in the U.S. recall.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables, meaning virtually everyone is exposed to some level of the chemical, Pfizer said. The "impurities" could increase cancer risk if people are exposed to them above acceptable levels over long periods of time, research says.
Pfizer says it believes the benefit of its recalled blood pressure-lowering medications outweighs the risk associated with the nitrosamine found in them (in this case, N-nitroso-quinapril), based on currently available data.
It also says it is not aware of any adverse event reports associated with the recalled medications to date.
"The products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program," Pfizer's statement said. "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. Patients currently taking the products should consult with their doctor about alternative treatment options."
The affected product lots were distributed to wholesalers and distributors in the U.S. and Puerto Rico from November 2019 to March 2022. See the full list of lot numbers for the affected products here and learn how to get refunds if needed.
Wholesalers and distributors with an existing inventory of lots listed in the recall should stop use and distribution and quarantine the products immediately, Pfizer said.
"Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process," its statement said. "Pfizer has notified direct consignees by letter to arrange for return of any recalled product."
The company says the U.S. Food and Drug Administration is aware of the recall.