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Very simply, Zantac is the brand name of a common heartburn medication called ranitidine. Zantac (ranitidine) is a type of drug known as an H2 blocker, or H2 antagonist, which decreases stomach acid by blocking histamine receptors in the stomach. It can be used to treat peptic ulcers, gastroesophageal reflux disease, and related conditions. Learn More.
Based upon recent testing by a popular independent laboratory and a resulting petition filed with the FDA, there are claims that Zantac (ranitidine) causes high levels of Nitrosodimethylamine (NDMA) exposure in patients. Essentially, the claims are that, aside from this testing, recent studies have confirmed that the unstable molecules of the medication break down in the digestive tract to create harmful levels of NDMA (especially if the ranitidine comes into contact with nitrites in the digestive tract). Based upon these claims, significant NDMA exposure could result from taking brand name or generic ranitidine products, regardless of where they were manufactured.
NDMA is listed by the International Agency for Research on Cancer (IARC) as a compound that is probably carcinogenic to humans, and by the US National Toxicology Program (NTP) as a compound reasonably anticipated to be a human carcinogen. In fact, NDMA is actually used in the research laboratory setting to induce cancer in rats.
Similar types of NDMA exposure have been linked to various primary cancers, including:
And, in more limited circumstances:
N-Nitrosodimethylamine commonly known as NDMA, is a yellow liquid which has no distinct odor. It is produced in the U.S. only for use as a research chemical. NDMA was used to make rocket fuel, but this use was stopped after unusually high levels of this compound were found in air, water, and soil samples collected near a rocket fuel manufacturing plant.
NDMA is very harmful to the liver of animals and humans. People who were intentionally poisoned on one or several occasions with unknown levels of NDMA in beverage or food died of severe liver damage accompanied by internal bleeding. Animals that ate food, drank water or breathed air containing high levels of NDMA over a period of days or several weeks also developed serious, non-cancerous, liver disease. When rats, mice, hamsters, and other animals ate food, drank water, or breathed air containing lower levels of NDMA for periods more than several weeks, liver cancer and lung cancer as well non-cancerous liver damage occurred. The high level short-term and low-level long-term exposures that caused non-cancerous liver damage and/or cancer in animals also usually resulted in internal bleeding and death. Although there are no reports of NDMA causing cancer in humans, it is reasonable to expect that exposure to NDMA by eating, drinking, or breathing could cause cancer in humans. Mice that were fed NDMA during pregnancy had offspring that were born dead or died shortly after birth. However, it is not known whether NDMA could cause the death of human babies whose mothers are exposed during pregnancy. It should be realized that exposure to NDMA does not mean that any effect on health will definitely occur.source
Laboratory analysis of ranitidine & nizatidine products
For reference, consuming up to 0.096 micrograms or 0.32 parts per million (ppm) of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure. FDA has set the acceptable daily intake limit for NDMA at 0.096 micrograms or 0.32 ppm for ranitidine. View Source.
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