Department of Defense Health Agency officials are urging military beneficiaries to stop taking the heartburn medication Zantac — both prescription and brand-name versions that contain the active ingredient ranitidine — and to talk with their doctors about using an alternative acid reducer. They are sounding the alarm after the Food and Drug Administration (FDA) on April 1 announced that it was pulling all versions of Zantac from the market due to the presence of a probable cancer-causing impurity known as NDMA.
NDMA, short for N-nitrosodimethylamine, “increases over time, and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity,” the FDA said in a Safety Communication.
Last September, online pharmacy Valisure, which tests all medications it dispenses, discovered elevated levels of NDMA in ranitidine, and alerted the FDA to this finding. Several recalls of ranitidine products ensued, and drug stores began pulling the products off their shelves out of concern, including the brand-name version of ranitidine, Zantac.
New testing and evaluation from third-party laboratories confirmed that NDMA in ranitidine products increased even under normal storage conditions and that the longer the period of time the drug was from manufacturing, the higher the level of NDMA. This can create circumstances that raise the level of NDMA above what is considered safe for daily human consumption, the FDA said. As a result, the agency called for the market removal of Zantac products.
Dozens of consumers are holding Zantac manufacturer Sanofi and other makers of ranitidine accountable, and have filed lawsuits against Big Pharma for putting profits ahead of patients. Beasley Allen attorneys Frank Woodson and Lisa Courson are actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, bladder or pancreas. If you or a loved one may have been affected, please contact us.