A cancer-causing chemical has been detected in Zantac, the popular medication taken by millions of people to treat heart burn.
While it’s unclear just how dangerous contaminated Zantac might be, the U.S. Food & Drug Administration (FDA) is urging those who rely on over-the-counter ranitidine products to consider switching to another antacid.
Those taking prescription versions should speak with their doctors before stopping treatment.
The FDA acted on Friday, after receiving a petition from Valisure, an online pharmacy company that found N-nitrosodimethylamine, or NDMA, in samples of Zantac.
“Every manufacturer and every type of Zantac or ranitidine that we’ve analyzed seems to have the same problem of the drug itself being very unstable and degrading, or even potentially reacting to, the condition in the human stomach to create NDMA,” David Light, CEO of Valisure, told CNBC.
The U.S. Environmental Protection Agency (EPA) lists NDMA as a “probable human carcinogen” based on animal studies linking the chemical to tumors of the liver, respiratory tract, kidney, and blood vessels. Exposure to high levels of NDMA has also been associated with liver damage in humans.
Name-brand Zantac is manufactured by Sanofi-Aventis, and is available in both prescription and over-the-counter forms. For now, the French company has indicated it won’t be conducting a Zantac recall.
“Sanofi takes patient safety seriously, and we are committed to working with the F.D.A.,” a spokesperson said in a statement to The New York Times. The over-the-counter version of Zantac “has been around for over a decade and meets all the specified safety requirements for use in the OTC market.”
NDMA is the same chemical compound found last year in generic versions of valsartan and other angiotensin II receptor blockers. Dozens of generic drug makers in the United States and 22 other countries were eventually forced to recall their valsartan, losartan, and irbesartan products, resulting in severe shortages.
The recalled medications contained ingredients supplied by companies in China and India. Roughly 80% of the ingredients used to manufacture drugs in the United States are sourced from those two countries. The valsartan recalls have sparked concerns over the safety of the American drug supply, and critics of the FDA maintain that the agency is too lax when it comes to regulating overseas manufacturers.
“I think this is another good example of how our regulations need to change,” Dinesh Thakur, a drug-safety advocate who exposed widespread quality problems as a former executive at the Indian drug maker Ranbaxy Laboratories, told The New York Times. “Things like this will never get caught, unless somebody is actually actively looking for stuff.”