Another Class of Antihypertensive Recalled

This week, Pfizer launched a nationwide recall of quinapril hydrochloride/hydrochlorothiazide (Accuretic), as well as two generics distributed by Greenstone, citing excess levels of a potential carcinogen.

The recall was triggered by the presence of N-nitroso-quinapril above the Acceptable Daily Intake level. However, there have been no reports of adverse events related to the nitrosamine contamination in these blood pressure-lowering medications.

“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,” Pfizer said in a press release.

Nevertheless, the company is asking that U.S. patients and distributors return the affected lots, which amount to 11 in total among the various affected formulations.

This recall follows a similar action in Canada, where regulators recalled eight lots of Accuretic earlier this month. There, however, patients had been told to continue taking the drug as long as they talk to their doctor about treatment alternatives going forward.

Also in early March, Pfizer was forced to recall another heart drug in Canada — the beta-blocker propranolol hydrochloride (Inderal-LA) — due to higher-than-acceptable levels of N-nitroso-propranolol.

Only last year, the company’s smoking cessation drug varenicline (Chantix) was placed under recall in the U.S. because of excess N-nitroso-varenicline.

The pharmaceutical industry as a whole is coming up on year 4 of nitrosamine-related recalls that started with generic valsartan.

The FDA says manufacturers have until October 2023 to implement changes that mitigate the potential for nitrosamine contamination in their products. For example, companies may opt for a supplier qualification program that prioritizes trusted makers of active pharmaceutical ingredients, the agency said.

Alternatively, manufacturers may consider the addition of antioxidants in drug design to inhibit nitrosamine formation, as well as the incorporation of sodium carbonate to neutralize a nitrosamine-friendly acidic environment.