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Zantac (ranitidine) is a popular heartburn medication. Approved in the 1980s, it was one of the first drugs to reach $1 billion in sales. It is used by many millions of people a year and is available both over-the-counter and by prescription.(1) (2)
As an over-the-counter drug, Zantac is approved for: (3)
At prescription strengths, Zantac is also approved to treat: (4)
Zantac belongs to a class of drugs called H2-receptor antagonists, or H2 blockers. H2 blockers reduce the amount of acid produced in the stomach.
Stomach acid is essential to digestion, but if stomach acid backs up into the esophagus, it can cause heartburn or acid reflux. (5)
Stomach acid is produced by specialized cells, called parietal cells, found in the lining of the stomach. These cells are partially activated by histamine, a molecule that serves many functions in the body, including secreting gastric acid to help digest food. (6) (7)
Histamine binds to histamine receptors in parietal cells, initiating a chain of chemical reactions that results in the secretion of hydrochloric acid. (8)
H2 blockers bind to histamine-2 receptors in parietal cells. This “blocks” the receptors from binding histamine, preventing the stimulation of acid secretion. (9)
Proton pump inhibitors (PPIs) are another type of stomach acid reducer.
Brands of PPIs include, but are not limited to:
PPIs and H2 blockers can temporarily reduce the amount of acid in the stomach, but in different ways. PPIs target the final stage of acid secretion in parietal cells. (10)
Proton pumps are embedded parts of cell membranes that move specific ions in or out of cells and their inhibition can prevent the secretion of stomach acid. (11)
PPIs, however, have also been linked to myriad adverse events.
Several lots of Zantac have been recalled recently due to the confirmed or potential presence of N-nitrosodimethylamine (NDMA), an organic compound that has been identified as a probable human carcinogen (cancer-causing). (12)
In June of 2019, an online pharmacy, Valisure, notified the U.S. Food and Drug Administration (FDA) they had discovered high levels of NDMA in some tested batches of ranitidine. (13)
Valisure’s screening revealed over 2 million nanograms of NDMA per tablet in tested batches. (14) After adjusting their tests to more closely resemble conditions inside the human stomach, levels of NDMA dropped to 300,000 nanograms per tablet, but the FDA’s acceptable daily intake limit for NDMA is 96 nanograms. (15)
Valisure’s discovery and Citizen Petition filed with the FDA prompted the FDA to conduct its own tests of different lots of ranitidine by many different manufacturers. The FDA used a different protocol and found much lower, though often still unacceptable levels of NDMA. (16) (17) (18)
In late September 2019, the FDA announced a voluntary recall of 14 lots of prescription ranitidine manufactured by Sandoz due to the presence of NDMA. (19) Two days later, the FDA announced a voluntary recall of Apotex Corp.’s over-the-counter generic and brand-name formulations of ranitidine labeled as Rite Aid, Walmart, or Walgreens brands. (20) More recalls were announced in October and November from multiple manufacturers and distributors. (21)
On December 4, 2019, the FDA asked manufacturers to test every lot of ranitidine before selling the drug to consumers. Lots that test above the acceptable daily intake level are not to be sold, and manufacturers must inform the FDA. (22)
NDMA is classified as a probable human carcinogen by the U.S. Environmental Protection Agency (EPA) and the World Health Organization’s (WHO) International Agency for Research on Cancer (IARC). (23) (24) NDMA is a byproduct of both natural and industrial processes. (25) It was once used in the production of rocket fuel. (26) (27)
People may be exposed to NDMA by: (28)
NDMA may form inside the human body when certain substances react with nitrites in the body. The FDA has advised consumers taking ranitidine to consider limiting their consumption of foods high in nitrites due to “some evidence that there may be a link between the presence of nitrites and the formation of NDMA in the body if ranitidine … is also present.” (29)
So far, these ranitidine products have been voluntarily recalled nationwide: (30) (31) (32)
One manufacturer, Valisure, believes the ranitidine molecule’s “inherent instability” (33) causes it to breakdown inside the human stomach to form NDMA. (34) They claim that “all manufacturers, brand or generic, and all lots of ranitidine-containing medications are affected.” (35)
A 2016 study by Stanford University and Syracuse University researchers found levels of NDMA in urine increased 400-fold after healthy test subjects consumed one 150 mg tablet of Zantac. (36)
Animal testing has shown NDMA induces development of tumors in the liver, kidney, and other organs in a variety of species exposed to NDMA. (37) Some studies link diets high in sources of NDMA (like cured meats) with cancers of the digestive tract. (38)