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Two blood pressure drugs have been recalled over unacceptable levels of cancer-causing chemicals known as nitrosamines. The medication defect is believed to have resulted from manufacturing processes, which have been known to trigger chemical reactions in consumer products. Long-term exposure to high levels of the compound could contribute to the development of several cancers, health bodies have warned.
The US Food and Drug Administration (FDA) announced the voluntary drug recall of the two blood pressure medications last week, after discovering nitrosamines levels exceeded the safety threshold.
The company Aurobindo Pharma USA, withdrew Quinapril and Hydrochlorothiazide Tablets USP in 20 mg and 12.5 mg doses, respectively.
The manufacturer has not yet received any reports of adverse events related to the drug recall, according to the FDA.
It has notified all its distributors to immediately discontinue the distribution of specific lots being recalled.
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The drug recall is the latest of several to be issued in recent years over similar concerns.
Other withdrawals have concerned the acid reflux medicine ranitidine and the diabetes drug metformin.
Nitrosamines are a class of organic compounds which are formed by natural chemical reactions.
These chemical reactions can occur in drugs during manufacturing or form naturally after the drug is stored or packaged.
The impurities are believed to increase the likelihood of cancer when people are exposed to above-acceptable levels over long periods of time.
The FDA explains: “Some nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.
“People taking drugs that contain [nitrosamines] at or below the acceptable intake limits every day for 70 years are not expected to have an increased risk of cancer.”
Nitrosamines can be found in an array of consumer products such as processed meats, alcoholic beverages, cosmetics and cigarette smoke.
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It may also naturally form inside the mouth or stomach if a consumer product contains precursors for nitrosamines.
This occurs mainly when the Ph levels in the mouth of the stomach are acidic, which allows the nitrates or nitrite added to food to combine with amines to form nitrosamines.
According to Science Direct: “Nitrosamines are considered to be strong carcinogens that may produce cancer in diverse organs and tissues including lung, brain, liver, bladder, stomach, oesophagus and nasal sinus.”
Not all cured meats have detectable levels of the compounds, but fried bacon has consistently been found to contain the carcinogen.
It’s known that nitrite and nitrate are often added to cured meats to prevent the formation of toxins.
Some seafood can also contain nitrosamines as a result of preparation methods like cooking or salt drying.
Anyone concerned by the drug recall is advised not to stop taking their prescription medications without consulting their health care provider first.
A doctor will make an informed decision about the safest steps to take if your drug has been recalled.
Aurobindo Pharma USA has been approached for comment.
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