Three blood pressure drugs made by pharmaceutical giant Pfizer have been recalled after they were found to contain a potential carcinogenic chemical compound.
Accuretic, along with two generic blood pressure medications licensed by the company, have been found to have elevated levels of nitrosamine, which can put someone at risk of developing cancer if exposed to elevated levels.
The Food and Drug Administration (FDA) says that some levels of the compounds are acceptable and commonly found in foods and drinks consumed every day, but chronic use of drugs with found impurities can be dangerous.
Pfizer voluntarily recalled the products on Monday and did not report any side effects related to the impurities. Last week, the Canadian branch of the company recalled another blood pressure drug, Inderal, for the same reasons.
Pfizer has voluntarily recalled Accuretic, a blood pressure drug that was found to contain nitrosamine impurities that can cause cancer with long-term exposure.
While small amounts of nitrosamine are safe, chronic exposure to large amounts has been linked to a variety of cancers.
“Nitrosamine impurities may increase the risk of cancer if people are exposed to them above the tolerable level and for a long period of time, but a person taking a drug containing nitrosamines at or below the tolerable daily intake limits every day for 70 years is not expected to that they will have an increased risk of developing cancer,” the FDA writes about nitrosamines.
The Pfizer recall includes a large number of drugs that were distributed in the United States and Puerto Rico between November 2019 and March 2022.
The agency recommends that people who take a drug that contains nitrosamine impurities stop taking it immediately.
On Tuesday, the day after the recall, the company’s stock price lost two percent of its value, falling to $53.08 a share as of 12:58 p.m.
This is despite a generally strong day for the market as of mid-day.
Pfizer has advised all current hypertension patients who have been treating their condition with the recalled drug to talk to their doctor about possible alternatives.
“Pfizer believes that the benefit/risk balance of the products remains positive based on currently available data,” the company said in a statement.
“While long-term use of N-nitroso-quinapril may be associated with a potential increased risk of cancer in humans, there is no immediate risk for patients taking this medication.”
Akkuretik is a combination of two different drugs, quinapril and hydrochlorothiazide.
Quinapril is an ACE inhibitor drug that prevents a person’s blood vessels from narrowing, helping to prevent high blood pressure.
Hydrochlorothiazide is a diuretic that makes a person urinate more. It can quickly get rid of sodium in the body, helping to lower a person’s blood pressure.
Both drugs are also widely used in other blood pressure medications.
Nitrosamines are often unintentionally found in processed foods as a by-product of a chemical reaction between various chemicals used in the process.
In recent days, Pfizer has recalled three blood pressure drugs, and the company’s Canadian branch recalled anaprilin for the same reasons just last week.
According to the FDA, “there are many reasons why nitrosamines may be present in drugs.”
“The FDA has found that the source of nitrosamines may be related to the drug’s manufacturing process, its chemical structure, or even the conditions in which they are stored or packaged.”
“As food and drugs are processed in the body, nitrosamines can also be formed.”
They can be found in everything: in some types of meat, in alcohol, in cigarettes and even in cosmetics.
Chronic overexposure to the compound has been linked to lung, brain, liver, kidney, bladder, and stomach cancers, among others.
The FDA says the recent increase in drug recalls due to the compound is largely the result of the agency and other groups having more accurate testing technology than in previous years.