If You Take This Common Medication, Talk to Your Doctor Now, FDA Warns

Having high blood pressure is a troublingly common condition in the U.S. According to the…

Having high blood pressure is a troublingly common condition in the U.S. According to the Centers for Disease Control and Prevention (CDC), 47 percent of American adults have been diagnosed with hypertension or are taking medicine to deal with it. But if you’re one of the millions of people using medication to treat high blood pressure, you should know about a safety recall that a major pharmaceutical company just issued. Read on to see which medicines are being pulled and if you should schedule an appointment with your doctor immediately.

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On March 21, Pfizer announced a voluntary recall on six lots of its Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/hydrochlorothiazide tablets used for the treatment of hypertension. The affected products were distributed to all 50 states and Puerto Rico from November 2019 through March 2022.

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Pfizer said it issued the recall after it was discovered that certain lots of the medication had levels of a nitrosamine, N-nitroso-quinapril, that exceeded the Food & Drug Administration’s (FDA) Acceptable Daily Intake (ADI) limit on nitrosamine of 26.5 ng/day.

“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables,” Pfizer wrote in the recall notice. “Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”

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The FDA began setting industry-wide acceptable limits for nitrosamine impurities in medication in 2020, according to the section of the agency’s site devoted to this ongoing problem. “Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at or below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” the FDA explains.

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On the same day as Pfizer’s recall announcement, pharmaceutical company Sandoz Inc. announced it was issuing a nationwide recall of 13 lots of Orphenadrine Citrate 100 mg Extended Release (ER) Tablets after a “nitrosamine impurity” was found during recent testing. Other medications that have been pulled from the market for the same reason in the past include the heartburn medication ranitidine (popularly sold over the counter as Zantac) and the diabetes medication metformin.

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Pfizer says it has not yet received any reports of adverse reactions to the recalled medications. However, the company suggests anyone taking the tablets should contact their doctor or healthcare provider immediately to determine whether their prescription is affected by the recall.

“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,” Pfizer wrote in its notice. “Patients currently taking the products should consult with their doctor about alternative treatment options.”

Anyone with questions about the products can also call claims management service Sedgwick at 888-843-0247 from 8 a.m. to 5 p.m. ET on weekdays for more information on how the tablets can be returned for a refund.

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