WASHINGTON — Pfizer has issued a recall for a medication used to treat high blood pressure, along with two generic versions of the drug, amid concerns over an impurity that has been linked to increased cancer risk.
According to the U.S. Food and Drug Administration, the drugmaker said Monday that six lots of its Accuretic tablets have higher-than-acceptable levels of nitrosamine. One lot of generic quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/hydrochlorothiazide tablets, both distributed by Greenstone, also contain the impurity and are included in the recall. A complete list of the affected lot numbers is available on the FDA website.
“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. 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,” the company said in a news release, adding that there is “no immediate risk” to people who take the medication.
The release went on to say the hypertension drugs lower blood pressure, reducing the risk of cardiovascular events such as strokes and myocardial infections.
“The products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program,” the release said. “To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data.”
The company urged patients taking the recalled drugs “to consult with their doctor about alternative treatment options.”
For more information about how to return the products for a refund, call Sedgwick at 1-888-843-0247.
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