The U.S. Food & Drug Administration (FDA) has ordered the immediate removal of all Zantac and ranitidine products from the market, after its investigation confirmed that a potentially cancer-causing contaminant may increase over time.
The confirmation will likely bolster claims pursued by dozens of plaintiffs who began filing Zantac lawsuits shortly after the popular heart burn drugs became the subject of controversy last year.
The impurity – N-nitrosodimethylamine (NDMA) – is considered a probable human carcinogen, as animal studies suggest exposure to high levels may increase the risk for cancer, including gastric, kidney, and liver cancer.
Over the summer, the online pharmacy Valisure informed the FDA that NDMA had been detected in every sample of Zantac and ranitidine it tested, often at levels far above the agency’s recommended daily limit of 96 nanograms. According to the company, the impurity likely resulted from the instability of the ranitidine molecule, which appeared to produce NDMA when subjected to conditions that mimicked digestion.
The FDA announced its investigation in September. Then in January, Emery Pharma disclosed that its own testing suggested ranitidine produced unacceptable levels of NDMA when subjected to high temperatures typically encountered during shipment and storage.
Both Valisure and Emery Pharma had petitioned the FDA for a Zantac recall, but the agency declined to do so while its investigation was pending. Nevertheless, various drug companies voluntarily removed their products from the market, while several major retailers – including CVS, Walmart, Walgreens, and Rite-Aid — stopped sales of the drugs.
According to a statement posted to the FDA’s website on April 1st, the agency’s investigation has confirmed that the amount of NDMA in Zantac products increases over time, even under normal storage condition. Levels also rise significantly when the drugs are stored at higher temperatures, including those typically encountered during distribution and handling by consumers. What’s more, the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA.
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.”
In addition to ordering a Zantac recall, the FDA is advising consumers not to use any over-the-counter ranitidine-containing medications in their possession. Those taking prescription versions should speak with their health care professional about other treatment options before stopping the medicine.
Because of the coronavirus pandemic, consumers should not return their Zantac and ranitidine products to their “drug take-back location,” but rather follow disposal instructions in the medication guide or insert — or follow the FDA’s recommended safe disposal steps on its website.