Pfizer is recalling some blood pressure drugs citing cancer risk

Pfizer is recalling some shipments of its blood pressure drug Accuretic, as well as authorized generic versions of the drug, saying a cancer-causing compound in those lots exceeded the acceptable daily intake.

The compound in the drug is nitrosamine, which is also found in water and beer, and some foods like bacon and grilled meat. It is thought to pose a low risk of cancer in patients who take the drugs for a long time.

Such recalls have become common in recent years as private labs and companies discovered carcinogenic contaminants, prompting widespread recalls, particularly of blood pressure drugs. In September 2020, the Food and Drug Administration urged companies to regularly screen for these compounds. The agency on Wednesday announced another nitrosamine-related recall for a Sandoz drug intended to relieve discomfort associated with painful musculoskeletal conditions.

In 2018, the FDA announced a recall of drugs containing valsartan after NDMA, a probable carcinogen, was discovered in them.

A spate of recalls ensued after Valisure, then a pharmacy company that regularly tests medicines for contamination, reported the presence of nitrosamine in ranitidine, an ingredient in the heartburn drug Zantac. Valisure asked the FDA to expand testing after it found ranitidine contained a type of nitrosamine called N-nitrosodimethylamine, or NDMA, which is considered a probable carcinogen.

Drugs like Metformin for people with diabetes and Chantix for those trying to quit smoking have also been recalled because of possible carcinogens.

Accuretic has relatively few users: around 1,300 people took it in 2020. Its generic formulation has more, around 192,000 users, according to data from IQVIA, an analytics company. The generic drug consists of the ingredients quinapril and hydrochlorothiazide and generated sales of around US$4.7 million in 2020, according to IQVIA data.

Credit…Food and Drug Administration

Pfizer said in a press release that it was not aware of any adverse events related to the Accuretic recall. It said the benefits of taking the drug outweighed the risks, adding that the drug lowered blood pressure and reduced the risk of stroke and heart attack. The company advised patients to talk to their doctors about alternative treatment options.

On Wednesday, David Light, one of Valisure’s co-founders, said: “We are now over three years after the initial discoveries of nitrosamine impurities in important drugs and continue to see the ripple effects growing.”

He also pointed out that his team had discovered benzene, a known carcinogen, in consumer products like sunscreen and body sprays, and that the FDA was even quicker to begin asking the industry to expand its own benzene testing. Pfizer is recalling some blood pressure drugs citing cancer risk

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