Pfizer has voluntarily issued a U.S.-based recall of some of its blood pressure medications due to “the presence of nitrosamine above the Acceptable Daily Intake (ADI) level.”  The company announced the recall over concerns that its Accuretic tablets and two equivalent generic versions distributed by Greenstone, quinapril and hydrochlorothiazide and quinapril HCI/hydrochlorothiazide, might cause cancer.The Food and Drug Administration (FDA) has cautioned that nitrosamines (a compound created from Nnitroso-quinapril) are commonly found in dairy products, green leafy vegetables and cured meats.  Yet only exposure above ADI levels over a long period of time can make the substance a carcinogen.

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In fact, WebMD states that “while the association of nitrate with cured meats causes some to worry about their cancer-causing effects, other studies show that the nitrates found in vegetables may actually help reduce the risk of cancer.  Studies suggest that eating foods rich in natural nitrates can help reduce [one’s] risk of a number of chronic health conditions, whereas eating foods high in added nitrates can cause health risks.”  The site explains further, “Nitrates on their own are not broken down by stomach acid.  Instead, [one’s] gut biome can beak down nitrate into nitrite, which can cause health complications such as increased risk of cancer.”  WebMD cites ham, bacon, deli meat, hot dogs, spinach, bok choy, lettuce and carrots as all being foods high in nitrates.The recalled products are used to help treat high blood pressure (also known as hypertension).  The five medications are designed to lower blood pressure and resolve associated symptoms.  They decrease the risk of dangerous heart issues and myocardial infarctions, which cause complications.  Pfizer recommends patients taking this medication talk to their doctors about finding alternative treatment options.The products were given to patients between November 2019 and March 2022 and include all of the following:Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 10/12.5 mgAccuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/12.5 mgAccuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/25 mgquinapril and hydrochlorothiazide tablets, 20/25 mgquinapril HCl/hydrochlorothiazide tablets, 20/12.5 mgquinapril HCl/hydrochlorothiazide tablets, 20/25 mg“Pfizer believes the benefit/risk profile of the products remains positive based on currently available data,” the company announced when pulling the medications, adding, “Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication.”  Leadership indicated that Accuretic has “a safety profile that has been established for over 30 years” and that, to date, “Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall.”The company also stated that wholesalers and distributors should discontinue use and distribution.  More information, including the lot numbers of the medications impacted by the Pfizer’s decision, as well as the expiration dates, configuration details, and more, can be found on its website.

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Pfizer recalls 3 types of blood pressure medication over possible cancer riskPfizer Recalls Another Blood Pressure MedicationPfizer Voluntary Nationwide Recall of Lots of ACCURETIC™ (quinapril HCl/hydrochlorothiazide), quinapril and hydrochlorothiazide Tablets, and quinapril HCl/hydrochlorothiazide Tablets Due to N-Nitroso- Quinapril ContentWebMD: Foods High in Nitrates