Pfizer says that it’s voluntarily recalling some of its blood pressure drug products and two authorized cheaper generic versions of the drug because of elevated levels of a potentially cancer-causing impurity.
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The pharmaceutical giant Moderna stated on March 21 that it’s “recalling six lots of Accuretic (quinapril HCl/hydrochlorothiazide) tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/ hydrochlorothiazide tablets that are used to treat the symptoms of high blood pressure.”
Pfizer stated that “the tablets, which were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from November 2019 to March, have been found to contain the presence of nitrosamines.”
According to the Food and Drug Administration (FDA),
“nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. While everyone is exposed to some level of nitrosamines, overexposure to the impurities for extended periods of time can lead to an increased risk of cancer.”
Drugs that contain levels of nitrosamines that are above the acceptable daily intake limits are recommended by the FDA to be recalled.
“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. Patients currently taking the products should consult with their doctor about alternative treatment options,” the company stated.
Pfizer also noted that the products “have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program.”