Ranitidine and NDMA have been associated together since the 1980s. While there is no NDMA contamination in Zantac, but it consists of both nitrite and dimethylamine, which, when combined, form the compound NDMA.
Unacceptable NDMA Levels in Zantac
During June 2019, the FDA was notified by online pharmacy Valisure that routine tests conducted in their laboratory showed a link between Zantac and a cancer-causing agent called NDMA. Valisure filed a petition to recall the drug, following which the FDA conducted a test itself and found the claims to be true.
What is NDMA?
NDMA is a yellow-colored, water-soluble liquid having no taste or odor. It is a popular cancer-causing agent among animals and is suspected of doing the same in humans as well. Moreover, it is most toxic to the human liver – just a single dose of the compound can stimulate tumors and mutate mice cells. Two grams of the compound taken per day can easily kill a person.
The Agency stated it for Toxic Substances and Disease Registry that NDMA was used in the production of rocket fuel, however, it was stopped due to the unacceptably high levels of the compound found in water, air, and soil near the manufacturing plant. The compound is, however, accidentally formed during the production process on various plants during reactions where alkylamines are involved.
WHO also released a report on NDMA stating that there is significant evidence about NDMA being a strong compound, while the IARC has also classified NDMA as being carcinogenic to humans.
NDMA’s link with Zantac
Ranitidine or Zantac is used to treat a condition of gastroesophageal reflux and duodenal and gastric ulcers. Many researches since the 1980s have shown evidence that ranitidine can form NDMA by reacting with nitrite present in the stomach. There is significant evidence about nitrosamines as being the etiological agents in triggering bladder cancer.