In early September, the Food and Drug Administration (FDA) released a statement that N-nitrosodimethylamine (NDMA) was detected in at least one manufacturer’s version of ranitidine, a common over-the-counter heartburn drug known as Zantac. In the following weeks, some manufacturers voluntarily recalled their own versions of the drug, and some of the nation’s largest retailers pulled Zantac/ranitidine from their shelves entirely.
NDMA is classified as a probable human carcinogen and is found in low levels of cigarettes, most foods, and even drinking water. The FDA has publicly stated that the levels of NDMA found were “low” and suggested that the risk posed to humans was inconclusive as of now.
The acceptable amount of NDMA for human consumption is believed to be 96 nanograms.
But unlike the highly-publicized recall of angiotensin receptor blockers (ARBs) in 2017, which involved low levels of NDMA contamination as a result of the manufacturing process, some researchers believe the NDMA in Zantac/ranitidine is actually a natural by-product of the molecular structure of the drug and leads to NDMA levels in the human body greater than 2.5 million nanograms.
A complaint recently filed in Colorado Federal Court noted that “a person would need to smoke at least 6,200 cigarettes to achieve the same levels of NDMA found in one 150 mg dose of Zantac” and the manufacturer knew this at least as early as 1981.