On April 1, 2020, the Food and Drug Administration told companies to stop selling Zantac, and they further urged consumers to throw away any form of the heartburn medicine that might be sitting in household medicine cabinets.
Most stores had already taken Zantac, also known as ranitidine, off their shelves last September when the FDA announced that the drug contains a type of carcinogenic nitrosamine (N-nitrosodimethylamine, or NDMA).
The FDA’s April actions attempted to rid the public of any exposure to Zantac drugs after finding that this contaminant could build up within the drug during long periods of storage.
What You Should Know About NDMA
Zantac contains high levels of NDMA, a chemical that can alter the structure of human Deoxyribonucleic acid (DNA). At levels that exceed the acceptable daily intake limit of .096 micrograms per day, the contaminant puts consumers at risk of developing cancer. The FDA published results from the testing of various lots of Sanofi Pharmaceutical’s over-the-counter ranitidine and found the range of NDMA levels to be between .01 and .36.
Of further concern, Scientific American reported the opinions expressed by David Light, CEO of analytical pharmacy Valisure. According to an article published on the topic, Light said he believed the problem of NDMA far exceeded that of contamination. Rather, Light suggested that Zantac might actually break down in the human body to form NDMA.
Science World Report recently wrote that either Zantac’s original ingredients are faulty or the wrong doses of NDMA seep into the drug during manufacturing. Chemical & Engineering News sheds additional light on the role that manufacturing processes might play. According to an April 20, 2020 article in the publication, the contaminant has been found in at least six drugs ingested by tens of millions of consumers each year, including diabetes drug metformin and blood pressure medication valsartan. The article further suggests that such contamination may result from side reactions during the synthesis of certain drugs, the manner in which unstable drug compounds break down, and contamination from recycled manufacturing solvents.
Massive industry research is currently underway to gain a better understanding of how NDMA presence in Zantac and other drugs reached such unacceptable levels.
The Human Impact
According to the Centers for Disease Control and Prevention (CDC), NDMA is “very harmful” to the liver. It has also been connected to both liver and lung cancer in animals exposed to low levels for periods exceeding several weeks.
The CDC also stated that it would reasonable to expect cancer in humans exposed to the contaminant by drinking, eating, or breathing. According to the agency, pregnant mice that were fed NDMA bore offspring that were either born dead or died soon after birth.
Consumers who have taken Zantac and have been diagnosed with cancer should speak to a physician about their concerns.