Pfizer is recalling some shipments of its blood pressure drug Accuretic, as well as authorized generic versions of the medication, saying that a cancer-causing compound in those lots exceeded the acceptable daily intake level.
The compound in the medication is found in water and beer, as well as some foods such as bacon and grilled meats. It is thought to pose a small risk of cancer to patients taking the drugs for a long time.
In recent years, private labs and companies have detected cancer-causing impurities and set off wide recalls, especially in blood pressure drugs. The FDA told companies to look for these compounds on a regular basis in September 2020. On Wednesday, the agency announced another recall for a drug meant to reduce pain in the joints.
The F.D.A. announced a recall of medications that contained valsartan after NDMA was found in them.
A wave of recalls ensued after Valisure, a pharmacy company that regularly tests medications for impurities, indicated the presence of nitrosamine in ranitidine, an ingredient in the blood pressure drug. The F.D.A. was petitioned by Valisure after ranitidine was found to have a type of nitrosamine called N-nitrosodimethylamine, or NDMA, which is considered a probable carcinogen.
Drugs such as Chantix, for people trying to quit smoking, have been recalled due to probable carcinogens.
About 1,300 people took Accuretic in 2020. According to data from IQVIA, there are more than 192,000 users of its generic formula. IQVIA data shows that the generic drug generated $4.7 million in sales in 2020.
Pfizer did not know of any adverse events related to the Accuretic recall. The benefits of taking the drug outweigh the risks, it said. The company told patients to talk to their doctors.
David Light, a founder of Valisure, said on Wednesday: "We are now over three years after the initial discoveries of nitrosamine impurities in major medications and continuing to see the ripple effects grow."
The F.D.A. asked the industry to broaden its own benzene testing after his team discovered benzene in consumer products.
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