Nearly a month after the U.S. Food and Drug Administration (FDA) called for the withdrawal of all brand-name and generic versions of Zantac (ranitidine) after detecting unsafe levels of a cancer-causing impurity in the drugs, the European Medicines Agency (EMA) suspended sales of the drug.
The impurity, called N-nitrosodimethylamine, or NDMA, is a common environmental contaminant that can be found in food and water. Research has shown exposure to NDMA can cause cancerous tumor growth in laboratory mice. The FDA has determined that consuming up to 96 nanograms of NDMA per day is reasonably safe based on lifetime exposure. However, the agency added, “sustained higher levels of exposure [to NDMA] may increase the risk of cancer in humans.”
In fall 2019, a third-party laboratory detected elevated levels of NDMA in some products containing ranitidine, the active ingredient in Zantac. Several recalls were issued and the FDA began conducting its own studies. On April 1, the agency determined that levels of NDMA could increase under normal storage conditions and pose risks to consumers, and called for the removal of all Zantac products.
The EMA launched its own investigation and, four weeks later, suspended sales of all Zantac products. “There is some evidence that NDMA may form from the degradation of ranitidine itself with increasing levels seen over its shelf life,” the EMA said in a press release. “It is not clear whether NDMA can also be formed from ranitidine inside the body. Some studies suggest that it can while others do not. Given the uncertainties, the CHMP has recommended a precautionary suspension of these medicines in the EU.”
Beasley Allen attorney Frank Woodson is actively investigating potential claims involving regular Zantac/ranitidine use 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.