Pfizer, Inc. announced on Mar. 21, 2022 that it was recalling three drugs used to treat high blood pressure due to an excessive amount of nitrosamines found in the tablets. The compounds can increase the risk of cancer if people are exposed to them at high levels over a period of time.1
Pfizer Issues Press Release with Details About Recalled Blood Pressure Drugs
Pfizer said it is recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets, which are distributed by Pfizer, as well as two authorized generics distributed by Greenstone (quinapril, hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) because nitrosamine is in the tablets at above the Acceptable Daily Intake (ADI) level. The company said it is recalling six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/hydrochlorothiazide tablets.2
The following recalled drug products were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from November 2019 to March 2022:3
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 10/12.5 mg
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/12.5 mg
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/25 mg
- quinapril and hydrochlorothiazide tablets, 20/25 mg
- quinapril HCl/hydrochlorothiazide tablets, 20/12.5 mg
- quinapril HCl/hydrochlorothiazide tablets, 20/25 mg
The National Drug Code, Lot Number, Expiration Date and other details of these products can be found in Pfizer’s press release publicizing the recall.
Nitrosamines: Genotoxic Chemical Carcinogens
According to a review in the scientific journal Mutation Research, nitrosamines form a large group of genotoxic chemical carcinogens that occur in the human diet. In environmental forms, nitrosamines can be formed endogenously in the human body.4
The scientific review stated that extensive experimental data suggests that humans are susceptible to carcinogenesis by N-nitroso compounds and that the presence of these compounds in some foods may be regarded as a risk factor for certain human cancers, such as cancer of the esophagus, stomach and nasopharynx.5
The U.S. Food and Drug Administration (FDA) maintains that everyone is exposed to some level of nitrosamines since they are common in water and foods, including cured and grilled meats, dairy products and vegetables.6
FDA Has Set “Acceptable Daily Intake” of Nitrosamines
The FDA has determined ADI limits for nitrosamines. If drugs on the market contain levels of nitrosamines above the ADI limits, the FDA recommends the manufacturer recall the drugs. The FDA states that nitrosamine impurities in drugs can increase the risk of cancer if people are exposed to high levels over a long period of time. However, the agency adds:
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.7
In a statement released to the public, Pfizer said:
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.8
Pfizer Recalled Anti-Smoking Drug in 2021 Due to High Levels of Nitrosamines
In 2021, Pfizer recalled all lots of its drug Chantix (also known as varenicline) due to the presence of high levels of nitrosamines. Chantix has been on the U.S. market since May 2006 when the FDA approved it as a prescription medication to treat adults over the age of 18 to stop smoking. The drug is generally prescribed for 12 to 24 weeks.9
After the recall, the FDA stated:
patients taking the recalled drug should continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different treatment”, The FDA added that, “The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.10
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1 Pfizer, Inc. Pfizer Voluntary Nationwide Recall of Lots of ACCURETIC™ (quinapril HCl/hydrochlorothiazide), quinapril and hydrochlorothiazide Tablets, and quinapril HCl/hydrochlorothiazide Tablets Due to N-Nitroso- Quinapril Content. Mar. 21, 2022.
4 Tricker AR, Preussmann R. Carcinogenic N-nitrosamines in the diet: occurrence, formation, mechanisms and carcinogenic potential. Mutation Research 1991 Mar-Apr; 259(3-4): 277-89.
6 U.S. Food and Drug Administration. Information about Nitrosamine Impurities in Medications. Nov. 18, 2021.
8 Romo V. Pfizer launches a recall of blood pressure drugs due to a potential carcinogen. NPR Mar. 22, 2022.
9 Acevedo N. Pfizer recalls all lots of anti-smoking drug Chantix over carcinogen presence. NBC News Sept. 18, 2021.