Pharmaceutical company Merck & Co. says it will fix the problem that caused contamination of its popular diabetes drugs with nitrosamines, which may cause cancer.
Merck found nitrosamines in Januvia, Janumet and Steglujan medications — trade names for the drug sitagliptin — which are used to treat Type 2 Diabetes.
“Merck has identified the root cause of the nitrosamine, NTTP, formation in certain batches of its sitagliptin-containing products and has submitted a detailed report of its findings to relevant health authorities,” the company said in a statement.
“The company has already instituted additional quality controls and expects to be able to consistently reduce NTTP levels to meet the long-term acceptable daily intake level this year, although the specific timeframe will be based on the progress of timing to institute process modifications and on engagement with” the U.S. Food and Drug Administration and other health authorities, it added.
Nitrosamines are organic compounds found widely in food, water, cosmetics, toys and the environment in general.
“Nitrosamines are a group of compounds that are created by chemical reactions involving nitrates, nitrites, and other proteins,” according to the National Capital Poison Control Center. “Nitrosamines are present in many of the foods we eat every day, including green leafy vegetables and processed meats such as bacon, ham, and sausage. The nitrosamine content of food varies with respect to food temperature, moisture, and cooking methods. For example, raw bacon contains minimal nitrosamines, whereas higher levels are found in crispy fried fatty bacon. Nitrosamines are also present in cosmetics, toys, and even condoms. Because they are found in tobacco smoke and motor vehicle emissions, nitrosamines are also present in the air that we breathe daily.”
“It is well established that nitrosamines can form endogenously from foods treated with sodium nitrite and that certain foods such as bacon and beer contain preformed nitrosamines (Lijinsky, 1999),” Dr. Joseph Jankovic says in the 2022 edition of Bradley and Daroff’s Neurology in Clinical Practice. “Although preformed nitrosamine levels in beer and nitrite levels have declined substantially since the 1980s, the small amounts of nitrosamines in food are nonetheless significant because of the possibility that humans are more sensitive to these carcinogens than laboratory rodents.”
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