The company said in a statement that it is recalling six lots of brand-name Accuretic tablets with nitrosamine levels above the acceptable daily intake, along with several lots of generic versions of this blood pressure drug. Everyone is exposed to some level of nitrosamines, which are found in water as well as foods including cured and grilled meats, dairy products, and vegetables, Pfizer said in its recall notice. Many medicines contain low levels of nitrosamines, and people can take them daily for decades without increasing their cancer risk. But nitrosamine levels in the recalled medicines were high enough that daily pills might eventually raise users’ cancer risk. “These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” Pfizer said. Studies have linked nitrosamines to an increased rate of death by certain cancers, including malignancies of the esophagus, oral cavity, and pharynx. Pfizer said it is not aware of any adverse events associated with nitrosamine impurities in the recalled lots of Accuretic tablets. “There is no immediate risk to patients taking this medication,” Pfizer said in its recall notice. “Patients currently taking the products should consult with their doctor about alternative treatment options.” There are many reasons why nitrosamines might be found in prescription medicines, according to the U.S. Food and Drug Administration (FDA). Sometimes these impurities are present because of a drug’s chemical structure, the way it’s manufactured, or how it’s stored or packaged. Nitrosamine impurities have previously been found in a wide range of medications, including blood pressure medicines known as angiotensin II receptor blockers (ARBs), the heartburn drugs ranitidine and nizatidine, and the diabetes drug metformin, according to the FDA. When impurities are detected, companies are required to take steps to prevent distribution of medicines containing nitrosamine levels above the acceptable intake limit set by the FDA of 26.5 nanograms per day (ng/day). This can include voluntary recalls. Pfizer has previously recalled lots of its smoking cessation drug Chantix because of high nitrosamine levels, according to the FDA. Sandoz Inc. issued a voluntary recall of its orphenadrine citrate extended release tablets, a treatment for pain from muscle spasms, the same day that Pfizer recalled Accuretic. Patients taking brand-name or generic versions of Accuretic should consult with their doctor to determine if their medication is covered by the recall, Pfizer advised. People who suspect they have a recalled lot of this medicine can call 888-843-0247 during weekday business hours to get information on how to return the pills and get a refund.
