In September 2019, online pharmacy Valisure notified the Food and Drug Administration (FDA) that it had detected unacceptable levels of a probable cancer-causing impurity in several forms of the heartburn drug Zantac. Scores of Zantac and generics containing the active ingredient ranitidine were recalled. Valisure CEO David Light told USA Today last fall that there were hints dating back to the 1980s that that Zantac could be dangerous to consumers.
Yet, it wasn’t until April 1, 2020, that the FDA called for the withdrawal of Zantac. The agency spent those long months evaluating study results, after which it determined that levels of NDMA, short for N-Nitrosodimethylamine, in Zantac could increase even under normal storage conditions, and could increase significantly when it was stored at high temperatures. And, the longer Zantac was from its manufacturing date, the greater the level of NDMA.
NDMA is a known environmental contaminant found in water and foods like meats, dairy products and vegetables. The FDA considers the consumption of up to 96 nanograms of NDMA per day reasonably safe, based on lifetime exposure. But at sustained higher levels, exposure to NDMA may increase the risk for cancer in humans.
According to information gathered for Valisure in its Citizen’s Petition to the FDA about the presence of NDMA in Zantac, original Zantac-maker Glaxo Research Group conducted several studies on Zantac in the 1980s that raised red flags about its safety. In a 1987, Glaxo researchers were concerned enough about cancerous nitroso compounds like NDMA in the drug that they specifically investigated gastric contents in human patients to look for the compounds. They concluded that there was no significant increase in NDMA in the samples after a 24-hour period. However, Light says, the testing used at the time was inadequate and less effective at detecting the impurity.
NDMA was again associated with Zantac decades later, in 2016, when Stanford University researchers tested the urine from 10 people to study the potential of NDMA contamination in drinking water. Each of the participants took a 150-milligram tablet of Zantac. Researchers noted, in what they called a “chance finding from a peripheral field,” levels of NDMA far greater than the FDA’s daily limits.
Light says the Stanford study and his own lab’s analysis shows that Zantac use poses risks to humans. “The negative effect of exposure to this drug and its formation of NDMA is something that has created a huge public health problem,” he said, “and we’re going to be dealing with it going forward.”
Beasley Allen attorneys Frank Woodson and Lisa Courson are actively investigating potential claims involving regular Zantac/ranitidineuse that may have led to cancer of the stomach, colon, intestines, kidneys, or pancreas. If you or a loved one may have been affected, please contact us.