The National Drug Authority (NDA) in Uganda is warning consumers that drugs containing ranitidine, including the brand-name Zantac, may contain a probable cancer-causing impurity called NDMA (N-Nitrosodimethylamine). As a result, the NDA began recalling the drugs on June 24, and is requiring all manufacturers of the medications to test for NDMA effective Aug. 1.
“NDMA is classified as a probable human carcinogen — a substance that could cause cancer, following exposure over time based on results from laboratory tests,” said NDA secretary David Nahamya. “All manufacturers of drugs with potential for nitrosamine impurities will be required to establish specifications and validated test methods for these impurities and carry out laboratory testing for confirmation of these impurities in the finished drug product to acceptable levels,” the NDA said.
Zantac is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome, gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.
The agency first alerted the public of the impurities in the drugs in October but at that time had not established what actions would be taken.
In October, the U.S. Food and Drug Administration (FDA) warned consumers in this country of the potential for Zantac and generics to contain NDMA, but it wasn’t until April that the agency took the bold move of ordering all Zantac products off the market. The action was spurred by a review of third-party testing that found that levels of NDMA could increase to unsafe levels in Zantac and ranitidine products even under normal storage conditions.
The FDA says that low levels of NDMA aren’t thought to increase the risk of cancer, but sustained higher levels of exposure may cause cancer in humans.
Attorneys with Beasley Allen Law Firm are currently investigating claims from those who have used Zantac, and developed certain types of cancer including liver, bladder, stomach, colon, kidney and pancreatic cancer. If you or a loved one was a regular user of Zantac or any other product containing ranitidine and have been diagnosed with cancer, we would like to talk with you. Contact Frank Woodson, one of our leading pharmaceutical attorneys in charge of Zantac cancer claims.