Nitrosamines: A Carcinogen Found in Popular Drugs

A lot of drugs used for heartburn, diabetes, hypertension and hypertension have been found to contain a a>=”https://www.theepochtimes.com/t-carcinogen”>carcinogen: nitrosamine.

Novartis, a Swiss drugmaker, discovered in 2018 that its blood pressure medication Valsartan had dangerous levels of nitrosamine. Over the next two years, there were over 1,400 product lots The U.S. Food and Drug Administration (FDA), recalled the products because they contained this chemical at levels that were above the acceptable intake limits.

As recently as Aug. 19, 2022, Merck’s blockbuster diabetes medication, Januvia, was found to be contaminated With nitrosamine. This resulted in a month-long investigation Merck. Januvia was not recalled in order to avoid drug shortages.

Recalled products include commonly used drugs like Metformin, losartan, ZantacAnd quinapril.

The following is an extract from the National Cancer InstituteSome nitrosamines can cause a variety of health problems. Cancer In laboratory animals. There is a risk that nitrosamines could cause cancer in humans. Rectum and proximal colonies, pancreatic, stomach, esophageal, mouth and pharynx cancers.

Nitrosamines: A Carcinogen Found Last Century

We have known about nitrosamines almost 80 years. British scientists John Barnes, Peter Magee, however, reported the discovery. Rodents were afflicted by liver tumors from nitrosamines 1956. Since Barnes’ and Magee’s discovery, awareness and concern about nitrosamines have impacted the pharmaceutical and food industries.

Products such as beer, bacon, and cured meats have been known to contain nitrosamines. Although this is concerning, the nitrosamine levels found in these products are quite common. Very low and undetectable. In pharmaceutical products, acceptable levels of nitrosamine range from 26.5–96 ng/day, depending on the Chemical composition of the nitrosamine.

One case of cancer per 100,000 is the acceptable level of potential carcinogens found in pharmaceuticals. The estimated risk for drug valsartan, for example, is between 12–30 cases per 100,000 people.

Research has examined the susceptibility of nitrosamines to interactions with biological compounds. When a href=”https://academic.oup.com/jn/article/133/3/965S/4688075″>nitrosamine Uses certain amino acids in conjunctionIt can cause genetic mutations that can lead to cancer in animal and cell models.

Which drugs have been recalled because of nitrosamine impurities?

Many drugs containing nitrosamines have been recalled since 2018. There are several medications that contain nitrosamines. Remember History is a result of nitrosamine impurities:

• Valsartan
• losartan
• irbesartan
• nizatidine
• Accuretic (quinapril HCl/hydrochlorothiazide)
• Accupril, quinapril
• generic quinapril/hydrochlorothiazide tablets
• Zantac (ranitidine)
• Chantix (varenicline)
• metformin
• rifampin

What causes nitrosamine contamination in drugs?

Nitrosamines Form When a secondary or third-order amine reacts to nitrous acid. The majority of sartan compounds have a tetrazole rings. The sodium nitrite is required to make this ring. The ring is formed from nitrosamine compounds because the chemicals used are amines. The origins of nitrosamine contamination remain a mystery, unlike Zantac and other sartan medication.

There are other factors that can contribute to nitrosamine impureties in pharmaceuticals. These include the use of nitrosating agent during production, the presence reactive elements in starting material, acidic manufacturing processes and the presence nitrosamine precursors within raw materials.

Other than these factors, nitrosamines can also be produced by metabolic processes in the body. Special attention should be given to the whole lifecycle of a drug—from manufacturing, storage, shipping, and metabolism—to reduce the risk of introducing nitrosamines into the body.

What should we do to lower the risk of being exposed to nitrosamine?

FDA recommends the addition of antioxidant compounds to pharmaceutical products. Vitamin C and vitamin E as nitrosamine-formation inhibitors. These compounds were found to be effective in inhibiting the formation of nitrosamines by over 80 percent according to one study.

An alternative approach is to raise the pH of the environment where the pharmaceutical is manufactured. This reduces the possibility of creating nitrous acid which is necessary for the creation of nitrosamine.

Individually, individuals can take responsibility and protect themselves against nitrosamine. Suggestion Habits that people can adopt Avoid cured meats and food additives. Choose organic products. Test your tap water for any nitrites or nitrates. Eat a diet high in vitamin C.

At the moment, FDA advises that individuals who are taking a medication that may have been recalled talk to their health care provider, as stopping medications without consulting one’s physician can be dangerous. To find out if your medication has been recalled, patients should call their pharmacist. To find an alternative medication, patients should contact their physician and pharmacist.

Drugs containing nitrosamine are still allowed to be sold despite concerns about contamination. August 2022 saw the introduction of the FDA temporarily allows Januvia sales By allowing impurities levels greater than the acceptable threshold

FDA made this decision because Januvia patients could be in danger if Januvia is stopped without consulting their doctor.