Pfizer is recalling several shipments of its blood pressure medication Accuretic, as well as authorized generic versions of the drug, saying a carcinogen in those batches exceeded acceptable daily intake levels.
The compound in the drug is nitrosamine, which is also found in water and beer, as well as some foods, including bacon and grilled meats. It is believed to pose a small risk of cancer in patients taking the drugs for long periods of time.
Such recalls have become common in recent years as private labs and companies have discovered cancer-causing impurities and caused major recalls, especially with blood pressure medications. In September 2020, the Food and Drug Administration urged companies to regularly look for these compounds. The agency announced another nitrosamine-related recall on Wednesday for a Sandoz drug intended to reduce discomfort associated with painful musculoskeletal conditions.
In 2018, the FDA announced a recall of drugs containing valsartan after NDMA, a likely carcinogen, was discovered in them.
A wave of recalls followed after Valisure, a drugstore company that regularly tests drugs for impurities, reported the presence of nitrosamine in ranitidine, an ingredient in the blood pressure drug Zantac. Valisure asked the FDA to expand testing after it was found that ranitidine contained a type of nitrosamine called N-nitrosodimethylamine or NDMA, which is considered a probable carcinogen.
Drugs such as metformin, for people with diabetes, and Chantix, for those trying to quit smoking, have also faced recalls related to likely carcinogens.
Accuretic has relatively few users: About 1,300 people took it in 2020. The generic formulation has more, about 192,000 users, according to data from IQVIA, an analytics company. The generic drug includes the ingredients quinapril and hydrochlorothiazide and generated sales of approximately $4.7 million in 2020, IQVIA data shows.
Pfizer said in a press release it was not aware of any side effects related to Accuretic’s recall. It said the benefits of taking the drug outweighed the risks, adding that the drug lowered blood pressure and reduced the risk of strokes and heart attacks. The company advised patients to talk to their doctor about alternative treatment options.
On Wednesday, David Light, a founder of Valisure, said, “We are now more than three years after the first discoveries of nitrosamine impurities in key drugs and the wrinkle effects continue to grow.”
He also noted that his team had discovered benzene, a known carcinogen, in consumer products, including sunscreen and body sprays, and that the FDA was even quicker to ask the industry to expand its own benzene testing.