New concerns are emerging over the presence of a known carcinogen in the compound used to make heartburn medication Zantac. Things have taken an interesting twist however, as researchers explore the possibility that the source of the contamination may be the Zantac itself.
The issue of NDMA contamination in Zantac and other drugs based on its main ingredient first came to light last year. That was when a test of a Zantac sample conducted by an online pharmacy returned a positive result for the compound. NDMA, or N-nitrosodimethylamine, is known to cause various types of cancer in humans. The positive result triggered a worldwide recall of Zantac that was eventually followed by the FDA issuing their own recall multiple weeks after the rest of the world had taken action.
Researchers have been puzzled over where the NDMA originated ever since. While initial investigations pointed to source laboratories in India, patterns in contamination led investigators to explore other possible avenues. Those investigations suggest that Zantac itself can produce NDMA on its own while it sits in storage.
Tests conducted by Alameda, California laboratory Emery Pharma show that the drug used in Zantac can produce NDMA over time when it is exposed to heat of various levels. Higher levels of heat produce more NDMA in less time. While the heat generated in storage units and various shipping containers could certainly prove adequate to start the production of NDMA, researchers are also testing whether storing Zantac at room temperature could create NDMA but at a slower rate. “The more you heat it, the more NDMA you generate,” says Emery CEO Ron Najafi. “I am worried that if it just sits at home at room temperature it could gradually generate NDMA.”
Tests have produced unsafe levels of NDMA in as little as five days, and Emery has called on the FDA to take immediate action to recall not only Zantac, but any drugs made with its main ingredients.
