Study Finds Zantac Use Increases Urinary Excretion of Carcinogenic Chemical NDMA

Research has found that Zantac, a popular drug used to treat heartburn, peptic ulcers and gastroesophageal reflux disease (GERD), increases urinary excretion of N-nitrosodimethylamine (NDMA), a carcinogenic chemical that has been linked to bladder cancer, stomach cancer, liver cancer, prostate cancer and other cancers. NDMA is classified as a probable human carcinogen, which means exposure to the chemical can cause cancer, and there have been multiple recalls of Zantac and generic ranitidine issued recently, due to concerns that the medications might contain unsafe levels of NDMA. If you or someone you know took Zantac or another ranitidine-based heartburn drug and you have since been diagnosed with cancer, contact an experienced Zantac injury lawyer as soon as possible to discuss your legal options. You may have grounds to file a lawsuit and pursue financial compensation for your injuries and medical expenses.

Research Linking Ranitidine to NDMA Exposure

Ranitidine (Zantac) is an extremely popular medication. Doctors write more than 15 million prescriptions for ranitidine every year for the prevention and treatment of heartburn and ulcers in the stomach and intestines and countless more patients buy the heartburn drug over the counter. According to the online pharmacy and private lab Valisure, which reported finding carcinogenic chemicals in certain lots of the blood pressure drug valsartan last year, NDMA appeared in every batch of ranitidine it tested, from every manufacturer, often at levels more than 3,000 times higher than the FDA’s daily intake limit. “Our finding is that this is an inherent instability of the ranitidine molecule. It just falls apart into NDMA,” says Valisure CEO David Light about the presence of NDMA in Zantac. “And this isn’t just Valisure yelling about something we happened to find. The foundation of this concern has been around for decades. We’re really just connecting the dots.”

Indeed, research looking at the presence of NDMA in ranitidine was published as far back as the 1980s and as recently as 2016. In one study published in the journal Carcinogenesis in 2016, researchers “confirmed the production of N-nitrosodimethylamine (NDMA), a potent carcinogen, by nitrosation of ranitidine under stomach-relevant pH conditions in vitro.” They also evaluated the urinary excretion of NDMA associated with the ingestion of ranitidine. To do so, the researchers collected urine samples from five adult males and five adult females over a 24-hour period before and after ranitidine consumption and analyzed the samples for residual ranitidine, ranitidine metabolites, NDMA, total -nitrosamines and dimethylamine. According to their results, after taking ranitidine, the urinary NDMA excreted over 24 hours increased 400-fold. Based on these findings, the researchers involved in the ranitidine study concluded that there is “a need to evaluate the risks attributable to NDMA associated with chronic consumption of ranitidine, and to identify alternative treatments that minimize exposure to N-nitrosamines.”

Understanding the Zantac/NDMA Controversy

The Zantac/NDMA controversy began in September 2019, when Valisure notified the U.S. Food and Drug Administration (FDA) that it had identified “extremely high levels” of NDMA in ranitidine products exceeding what the FDA considers acceptable. The FDA conducted its own testing and found that some brand name and generic medications containing ranitidine, including Zantac, contained a nitrosamine impurity called N-nitrosodimethylamine at low levels. The agency suspects that the NDMA found in Zantac is related to flaws in the manufacturing process, but Valisure maintains that the problem stems from the active ingredient, ranitidine. Due to concerns about the cancer-causing chemical and the potential health risks it poses for people who regularly use ranitidine to prevent and treat heartburn, ulcers and GERD, several drug manufacturing companies have voluntarily recalled their ranitidine products and many pharmacies have suspended ranitidine sales and pulled the drugs off their shelves, including CVS, Walmart, Rite Aid and Walgreens.

NDMA Contamination and Valsartan Recalls

NDMA is the same carcinogenic chemical that was found in the generic blood pressure medications valsartan, losartan and irbesartan, which were subjected to multiple recalls beginning last year, amid concerns about the potential for the medications to cause cancer. Initially, it was believed that the presence of NDMA in ranitidine (Zantac) was linked to the NDMA contamination in those recalled valsartan products, the majority of which were manufactured at facilities in China and India. An internal investigation of the NDMA impurity in the recalled valsartan products revealed that the contamination likely occurred as a byproduct of the manufacturing process. However, there is a growing body of evidence suggesting that ranitidine itself, Zantac’s active ingredient, may be unstable and prone to breaking down into NDMA under certain conditions, including those occurring in the human digestive tract. If that is the case, anyone taking brand name Zantac or generic ranitidine could be exposed to potentially harmful levels of NDMA, which can lead to cancer.