The findings of two small studies conducted by the U.S. Food and Drug Administration (FDA) question whether Zantac’s active ingredient, ranitidine, converts into a cancer-causing chemical called N-nitrosodimethylamine (NDMA). The FDA researchers argue that their findings do not support the conclusion that ranitidine is converted to NDMA in otherwise healthy individuals. However, critics argue that the studies are small, limited in scope, and do not accurately reflect how the heartburn drug likely responds as it passes through the body of a typical Zantac user. If you or someone you know was diagnosed with cancer after taking Zantac for heartburn or another similar condition, we can help. Contact us today to discuss the possibility of filing a Zantac cancer lawsuit against the manufacturer of the popular heartburn medication.
NDMA is a potent human carcinogen, the presence of which led to widespread recalls of valsartan, losartan, irbesartan and other generic blood pressure medications that were found to contain dangerously high levels of the chemical as early as 2018. Unlike those recalls, however, the NDMA in Zantac was found to have occurred not as a byproduct of changes made to the generic drug manufacturing process, but rather as a result of ranitidine’s exposure to high temperatures during transportation and storage, or even as the drug passes through the human body. The risk of ranitidine converting into NDMA and potentially putting Zantac users at risk for cancer is what led to Zantac being removed from the market in April 2020. Now, the topic is up for debate once again, as FDA researchers examine the circumstances under which Zantac may produce NDMA.
The two new Zantac studies both raise questions about whether Zantac converts into NDMA inside the human body, at least among young, otherwise healthy users. In the first study, published in the Journal of the American Medical Association (JAMA) on June 28, the researchers conducted a one-month clinical trial in order to evaluate the 24-hour urinary excretion of NDMA after administration of ranitidine compared with a placebo. During the trial, 18 healthy participants were given 300 mg of Zantac or a placebo and were fed a diet of either non-cured meats or cured meats, which naturally contain NDMA. According to the researchers’ findings, “Oral ranitidine (300 mg), compared with placebo, did not significantly increase 24-hour urinary excretion of NDMA when administered with a noncured-meats diet or a cured-meats diet.”
In the second study, also published in JAMA on June 28, researchers conducted an in vitro analysis of 150-mg ranitidine tablets added to simulated gastric fluid, designed to replicate the circumstances under which ranitidine apparently converts into NDMA as it is digested in the human body. The researchers concluded that the ranitidine tablets “did not convert to NDMA in simulated gastric fluid with physiologic nitrite concentrations.” Based on their findings, they reported that nitrite concentrations would have to be “50-fold greater than the upper range of physiologic gastric nitrite concentrations at acidic pH” before ranitidine would produce NDMA.
Before it was recalled, Zantac was one of the most popular heartburn drugs on the market, used by millions of people to reduce the amount of acid in the stomach and relieve symptoms of heartburn, acid indigestion and gastroesophageal reflux disease (GERD). There are already hundreds of Zantac lawsuits pending in courts across the country, each of which involves similar allegations that exposure to high levels of NDMA in Zantac caused former users to develop cancer, and more claims are expected as the potential link between Zantac and cancer becomes more widely recognized.
It remains unclear what effect, if any, these small FDA studies will have on the ongoing Zantac litigation, though it is worth noting that the research is extremely limited and does not mean there is no longer cause for concern regarding the potential link between Zantac and cancer. In an editorial published in the same medical journal on June 28, C. Michael White, PharmD and Adrian V. Hernandez, MD, PhD note that “an in vitro study and a small phase 1 normal-participant study are far from definitive evidence.” If you believe you have been adversely affected by alleged Zantac side effects, do not hesitate to speak to an experienced Zantac cancer attorney about your legal options.