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Pfizer Recalls Three Blood Pressure Drugs Due to Cancer Causing Compound

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

Big Pharma Pfizer has recalled three of its blood pressure medications after it was discovered they contain a potentially cancer-causing compound.

Accuretic, along with two generic blood pressure medications licensed by the company, were found to have elevated levels of nitrosamine, which can put someone at risk of cancer if they are exposed to elevated levels.

The Food and Drug Administration (FDA) reports that some levels of the compounds are ok, and frequent in food and drink consumed everyday, but consistent use of drugs with detected impurities can prove dangerous.

‘Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but 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,’ the FDA writes about nitrosamines.

Pfizer’s recall includes lots of the drug that were distributed around the U.S. and Puerto Rico from November 2019 to March 2022. 

The agency recommends people that are taking a drug that is discovered to have nitrosamine impurities to immediately stop.

Nitrosamines have no known industrial use. However, they can be found in processed foods as unintentional by-products of food preparation and processing. Nitrosamines are formed by a reaction between nitrates or nitrites and certain amines. Nitrosamines and/or their precursors can be found in diverse consumer products such as processed meats, alcoholic beverages, cosmetics, and cigarette smoke. Nitrosamines can also be formed in the mouth or stomach if the food contains nitrosamine precursors. Under acidic pH in the mouth or stomach, nitrite or nitrates added to food or naturally occurring may combine with amines to form nitrosamines. In recent years, it has been discovered that disinfection of drinking water with dichloramine may result in the formation of trace levels of nitrosamines.

The Zantac lawsuits involve this compound as well.  The US FDA announced they had discovered, “that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.

In the summer of 2019, the FDA learned and reported that some generic versions of the angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities that don’t meet the agency’s safety standards. ARBs, including valsartan, irbesartan, losartan and others, are a class of medicines used to treat high blood pressure and heart failure. Nitrosamine impurities, including N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), are probable human carcinogens. These two substances are known environmental contaminants and found in water and foods, including meats, dairy products and vegetables. But their presence in drug products is not acceptable.

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