Billion-dollar drugs pulled from the market for carcinogenic contamination less than that found in a single serving of grilled chicken.
Cancer-Causing NDMA in Medications (Zantac, Metformin) and Meat
Below is an approximation of this video’s audio content. To see any graphs, charts, graphics, images, and quotes to which Dr. Greger may be referring, watch the above video.
In 2018, one of the bestselling blood pressure drugs, valsartan—sold as Diovan—was found to be contaminated by the “probably carcinogenic” nitrosamine known as N-nitrosodimethylamine (NDMA). It’s believed that approximately 20 million people worldwide were prescribed the drug tainted with this contaminant whose cancer risk has been shown to exceed that of many known potent carcinogens, including asbestos, benzo[a]pyrene, and PCBs.
The U.S. Food and Drug Administration (FDA) estimated that taking the drug for a few years could cause cancer in as many as 1 in 8,000 people, whereas the European equivalent of the FDA estimated the cancer risk could be as high as 1 in 5,000. It is unlikely, researchers wrote in this Spring 2019 paper, that drugs like valsartan are a unique case. And indeed, a few months later, the FDA announced it had found NDMA in ranitidine.
Ranitidine, the acid reflux drug sold as Zantac, is one of the most prescribed drugs on the planet, in addition to being sold over the counter. Give people a single tablet and the amount of NDMA flowing through their bodies jumps up more than a hundred-fold.
Then in 2020, some formulations of metformin, a popular diabetes drug sold as Glucophage, were found to be contaminated. The finding of NDMA in common medicines led the FDA to call for the immediate withdrawal of all Zantac from store shelves, yanking the drug from the market because their testing showed NDMA levels could in some circumstances exceed the acceptable daily intake limit of 96 nanograms per day. It was so bad that the FDA found levels of this carcinogenic contaminant NDMA in Zantac similar to the levels you would expect to be exposed to if you ate grilled or smoked meats!
Wait, what?
NDMA has not only been found in contaminating drugs. It is a known byproduct from pesticide manufacturing, leather tanning, and tire plants, and is found in multiple foods and beverages, including processed meat and beer. Now that we know NDMA can transfer through the placenta, this may explain the relationship between maternal cured meat consumption during pregnancy and the risk of childhood brain tumors. For example, hot dog consumption during pregnancy may increase childhood brain tumor risk by 33 percent or sausage consumption may increase it by 44 percent. Bacon consumption may increase childhood brain tumor odds by 60 or 70 percent. But it’s not just processed meat. Researchers have found it in poultry products as well.
A single serving of chicken contains more than 100 nanograms of NDMA. Remember how the FDA said the acceptable daily intake limit is 96 nanograms per day? Half of a chicken breast contains 110.
Now, raw poultry doesn’t have any; it’s the cooking process. In fact, the dry-heat cooking of meat, like broiling or grilling, even creates airborne NDMA, releasing this very potent carcinogenic compound into the air. So, even if you’re only getting a salad or something in a charcoal grill restaurant, just being indoors where meat is being cooked could pose a significant cancer risk.
These nitrosamines are also found in cigarette smoke, and pressure was put on the tobacco industry to try to remove them, arguing that there is simply no logical reason why a removable carcinogen should be allowed to remain in a consumer product. That’s the same reason Zantac was yanked from store shelves.
Okay, so let me get this straight.
One of the best-selling drugs in history was pulled from the market—a drug that brought in billions of dollars—because it contained a probable carcinogen that exceeded the acceptable daily limit, but there may be more of the contaminant in a single serving of chicken! So, my question is: why aren’t they pulling the poultry off the shelves as well?
Please consider volunteering to help out on the site.
- Sörgel F, Kinzig M, Abdel-Tawab M, et al. The contamination of valsartan and other sartans, part 1: New findings. J Pharm Biomed Anal. 2019;172:395-405.
- Gushgari AJ, Halden RU. Critical review of major sources of human exposure to N-nitrosamines. Chemosphere. 2018;210:1124-36.
- Gottlieb S. FDA Statement on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings. FDA.gov. August 30th, 2018.
- EMA. Update on review of recalled valsartan medicines: preliminary assessment of possible risk to patients. ema.europa.eu. February 8, 2018.
- FDA. Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. FDA.gov. September 13, 2019.
- Zeng T, Mitch WA. Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine [retracted in: Carcinogenesis. 2021 Jul 16;42(7):1008]. Carcinogenesis. 2016;37(6):625-34.
- Adamson RH, Chabner BA. The Finding of N-Nitrosodimethylamine in Common Medicines. Oncologist. 2020;25(6):460-2.
- FDA. FDA alerts patients and health care professionals to nitrosamine impurity findings in certain metformin extended-release products. FDA.gov. May 28, 2020.
- FDA. FDA requests removal of all ranitidine products (zantac) from the market. FDA.gov. April 1, 2020.
- FDA. Questions and answers: NDMA impurities in ranitine (commonly known as zantac). FDA.gov. April 1, 2020.
- FDA. Statement on new testing results, including low levels of impurities in ranitidine drugs. FDA.gov. November 1, 2019.
- Wagner JA, Colombo JM. Medicine and Media: The Ranitidine Debate. Clin Transl Sci. 2020;13(4):649-51.
- Annola K, Heikkinen AT, Partanen H, Woodhouse H, Segerbäck D, Vähäkangas K. Transplacental transfer of nitrosodimethylamine in perfused human placenta. Placenta. 2009;30(3):277-83.
- Huncharek M, Kupelnick B. A meta-analysis of maternal cured meat consumption during pregnancy and the risk of childhood brain tumors. Neuroepidemiology. 2004;23(1-2):78-84.
- Lee HS. Literature compilation of volatile N-nitrosamines in processed meat and poultry products - an update. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2019;36(10):1491-500.
- Kim H, Tcha J, Shim M-y, Jung S. Dry-Heat Cooking of Meats as a Source of Airborne N-Nitrosodimethylamine (NDMA). Atmosphere. 2019; 10(2):91.
- Gray N, Boyle P. The case of the disappearing nitrosamines: a potentially global phenomenon. Tob Control. 2004;13(1):13-6.
- Kolata G. Companies Search for Next $1 Billion Drug. The New York Times. November 28, 1988.
Motion graphics by Avo Media
Below is an approximation of this video’s audio content. To see any graphs, charts, graphics, images, and quotes to which Dr. Greger may be referring, watch the above video.
In 2018, one of the bestselling blood pressure drugs, valsartan—sold as Diovan—was found to be contaminated by the “probably carcinogenic” nitrosamine known as N-nitrosodimethylamine (NDMA). It’s believed that approximately 20 million people worldwide were prescribed the drug tainted with this contaminant whose cancer risk has been shown to exceed that of many known potent carcinogens, including asbestos, benzo[a]pyrene, and PCBs.
The U.S. Food and Drug Administration (FDA) estimated that taking the drug for a few years could cause cancer in as many as 1 in 8,000 people, whereas the European equivalent of the FDA estimated the cancer risk could be as high as 1 in 5,000. It is unlikely, researchers wrote in this Spring 2019 paper, that drugs like valsartan are a unique case. And indeed, a few months later, the FDA announced it had found NDMA in ranitidine.
Ranitidine, the acid reflux drug sold as Zantac, is one of the most prescribed drugs on the planet, in addition to being sold over the counter. Give people a single tablet and the amount of NDMA flowing through their bodies jumps up more than a hundred-fold.
Then in 2020, some formulations of metformin, a popular diabetes drug sold as Glucophage, were found to be contaminated. The finding of NDMA in common medicines led the FDA to call for the immediate withdrawal of all Zantac from store shelves, yanking the drug from the market because their testing showed NDMA levels could in some circumstances exceed the acceptable daily intake limit of 96 nanograms per day. It was so bad that the FDA found levels of this carcinogenic contaminant NDMA in Zantac similar to the levels you would expect to be exposed to if you ate grilled or smoked meats!
Wait, what?
NDMA has not only been found in contaminating drugs. It is a known byproduct from pesticide manufacturing, leather tanning, and tire plants, and is found in multiple foods and beverages, including processed meat and beer. Now that we know NDMA can transfer through the placenta, this may explain the relationship between maternal cured meat consumption during pregnancy and the risk of childhood brain tumors. For example, hot dog consumption during pregnancy may increase childhood brain tumor risk by 33 percent or sausage consumption may increase it by 44 percent. Bacon consumption may increase childhood brain tumor odds by 60 or 70 percent. But it’s not just processed meat. Researchers have found it in poultry products as well.
A single serving of chicken contains more than 100 nanograms of NDMA. Remember how the FDA said the acceptable daily intake limit is 96 nanograms per day? Half of a chicken breast contains 110.
Now, raw poultry doesn’t have any; it’s the cooking process. In fact, the dry-heat cooking of meat, like broiling or grilling, even creates airborne NDMA, releasing this very potent carcinogenic compound into the air. So, even if you’re only getting a salad or something in a charcoal grill restaurant, just being indoors where meat is being cooked could pose a significant cancer risk.
These nitrosamines are also found in cigarette smoke, and pressure was put on the tobacco industry to try to remove them, arguing that there is simply no logical reason why a removable carcinogen should be allowed to remain in a consumer product. That’s the same reason Zantac was yanked from store shelves.
Okay, so let me get this straight.
One of the best-selling drugs in history was pulled from the market—a drug that brought in billions of dollars—because it contained a probable carcinogen that exceeded the acceptable daily limit, but there may be more of the contaminant in a single serving of chicken! So, my question is: why aren’t they pulling the poultry off the shelves as well?
Please consider volunteering to help out on the site.
- Sörgel F, Kinzig M, Abdel-Tawab M, et al. The contamination of valsartan and other sartans, part 1: New findings. J Pharm Biomed Anal. 2019;172:395-405.
- Gushgari AJ, Halden RU. Critical review of major sources of human exposure to N-nitrosamines. Chemosphere. 2018;210:1124-36.
- Gottlieb S. FDA Statement on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings. FDA.gov. August 30th, 2018.
- EMA. Update on review of recalled valsartan medicines: preliminary assessment of possible risk to patients. ema.europa.eu. February 8, 2018.
- FDA. Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. FDA.gov. September 13, 2019.
- Zeng T, Mitch WA. Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine [retracted in: Carcinogenesis. 2021 Jul 16;42(7):1008]. Carcinogenesis. 2016;37(6):625-34.
- Adamson RH, Chabner BA. The Finding of N-Nitrosodimethylamine in Common Medicines. Oncologist. 2020;25(6):460-2.
- FDA. FDA alerts patients and health care professionals to nitrosamine impurity findings in certain metformin extended-release products. FDA.gov. May 28, 2020.
- FDA. FDA requests removal of all ranitidine products (zantac) from the market. FDA.gov. April 1, 2020.
- FDA. Questions and answers: NDMA impurities in ranitine (commonly known as zantac). FDA.gov. April 1, 2020.
- FDA. Statement on new testing results, including low levels of impurities in ranitidine drugs. FDA.gov. November 1, 2019.
- Wagner JA, Colombo JM. Medicine and Media: The Ranitidine Debate. Clin Transl Sci. 2020;13(4):649-51.
- Annola K, Heikkinen AT, Partanen H, Woodhouse H, Segerbäck D, Vähäkangas K. Transplacental transfer of nitrosodimethylamine in perfused human placenta. Placenta. 2009;30(3):277-83.
- Huncharek M, Kupelnick B. A meta-analysis of maternal cured meat consumption during pregnancy and the risk of childhood brain tumors. Neuroepidemiology. 2004;23(1-2):78-84.
- Lee HS. Literature compilation of volatile N-nitrosamines in processed meat and poultry products - an update. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2019;36(10):1491-500.
- Kim H, Tcha J, Shim M-y, Jung S. Dry-Heat Cooking of Meats as a Source of Airborne N-Nitrosodimethylamine (NDMA). Atmosphere. 2019; 10(2):91.
- Gray N, Boyle P. The case of the disappearing nitrosamines: a potentially global phenomenon. Tob Control. 2004;13(1):13-6.
- Kolata G. Companies Search for Next $1 Billion Drug. The New York Times. November 28, 1988.
Motion graphics by Avo Media
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Cancer-Causing NDMA in Medications (Zantac, Metformin) and Meat
LicenseCreative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)
Content URLDoctor's Note
NDMA is a nitrosamine, a class of carcinogens also found in processed meat. See, for example, How Much Cancer Does Lunch Meat Cause?
How can you make meat less cancer-causing? See Carcinogens in Meat.
Is Organic Meat Less Carcinogenic? Check out the video to find out.
Note: The article shown at minute 1:04 has since been retracted due to analytical artifacts, but the principal findings have been replicated elsewhere.
Update: In 2022, I release two new videos on cancer and processed meat. Check out IARC: Processed Meat Like Bacon Causes Cancer and How Much Cancer Does Processed Meat Cause?
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