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The drug contains amounts of nitrosamines that exceed the FDA’s acceptable daily intake.
If you take medication for high blood pressure, you may want to double-check its label. Pfizer just issued a voluntary recall of its popular blood pressure med, Accuretic, along with two generic versions (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) due to the presence of a potentially cancer-causing impurity known as nitrosamines.
More specifically, the medications contain levels of N-nitroso-quinapril, a type of nitrosamine, that are above the Food and Drug Administration’s (FDA) recommended Acceptable Daily Intake (ADI) level. According to a press release from the company, Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/ hydrochlorothiazide tablets. For a full list of the affected lots, check here.
The FDA reports that people who are exposed to excessive levels of nitrosamines—a compound naturally found in water and some foods, including cured and grilled meats—over long periods of time may experience an increased risk of cancer.
Over the last two years, the FDA has investigated the presence of this potential carcinogen in drugs, and has urged pharmaceutical companies to recall medications that exceed the internationally set ADI levels. Accuretic is one of multiple drugs being pulled off of shelves in response—Viona Pharmaceuticals, Inc. recalled lots Metformin, a popular diabetes drug, in January for similar reasons.
Accuretic is used to treat hypertension—a growing worldwide problem—and reduce risk of cardiovascular events such as strokes. In Pfizer’s release, the company states that no adverse health effects related to the recall have been assessed and there is no immediate risk to patients taking the medication, despite long-term nitrosamine exposure concerns.
As these recalls likely continue to roll out, the FDA urges affected patients not to stop taking their medications, but to consult with their doctor about alternative treatment options. Pfizer advises providers of the drug to “stop use and distribution and quarantine the product immediately.”
If you have any of the impacted medications, Pfizer recommends calling 888-843-0247 for instructions on how to return them and be reimbursed for their cost. If you experience any adverse effects related to the recall, you can report them using this form.
The FDA’s efforts to determine the source of nitrosamine impurities is ongoing, and the agency vows to keep the public informed along the way.
