Zantac NDMA Contamination Found in 75% of Tablets Tested By Australian Investigators

As officials worldwide continue to investigate problems involving Zantac contamination with cancer-causing impurities, a statement by Australian drug regulators indicate that three-quarters of tablets tested were found to contain high levels of the carcinogen N-nitrosodimethylamine (NDMA).

According to a report by ABC News, Australia’s Therapeutic Goods Administration (TGA) has tested at least 135 different batches of Zantac and generic ranitidine, finding that 75% of the tablets contained more than three parts per million of NDMA, raising health concerns.

Zantac (ranitidine) has been on the market for decades, and is widely used by millions of Americans for treatment of heart burn and acid reflux. However, increasing evidence suggests the active ingredient in Zantac is inherently unstable, and may convert to NDMA when stored at high temperatures, such as in a car, inside the human stomach.

The problem was first reported in the U.S. by the online pharmacy Valisure, which filed a citizen’s petition calling for a Zantac recall in September. Shortly after, the FDA issued a warning about the potential risk of Zantac NDMA contamination, indicating that the agency is continuing to investigate the issue.

Over the past month, a number of drug manufacturers have stopped distributing the drugs and most major pharmacy chains in the U.S. have removed Zantac from shelves, but the FDA has not announced a formal recall for the popular heartburn drug or provided instructions to consumers about what to do with pills they already have..

In Australia, a number of different forms of Zantac were recalled on October 4, due to the potential cancer risk from NDMA. The TGA issued an update to the situation on October 15, but does not mention the testing results, which ABC News indicates are still being validated. However, the TGA did warn that the recalls and other actions have resulted in a Zantac shortage.

“Ranitidine tablets and oral liquids are now in short supply as a number of commonly-used brands have been recalled from pharmacies, hospitals, wholesalers, and other retail outlets, such as supermarkets and online stores,” the TGA press release states. “Additional brands may be recalled as TGA continues testing and discussions with companies that supply ranitidine.”

According to Valisure’s testing, levels of NDMA in Zantac were in excess of 3,000,000 nanograms (ng) per 150 mg tablet, which is 26,000 times higher than the FDA’s permissible daily intake for the chemical.

The excessive levels were detected across all brands of Zantac and all lots, and Valisure indicated research dating back 20 years has included warning signs that the drug might be a problem.

In the United States, a number of individuals are now investigating potential Zantac lawsuits, involving allegations that exposure to NDMA in the drugs caused them to develop bladder cancer, stomach cancer, small intestine cancer, colorectal cancer, esophageal cancer and other injuries.

Plaintiffs allege that the diagnosis could have been avoided if the drug makers had disclosed the risk of Zantac NDMA contamination, as other alternative heartburn treatments would have been used. Valisure testing confirmed that no detectable levels of NDMA were found in eight other popular alternatives to Zantac, including Tagamet, Pepcid, Prilosec, Nexium, Prevacid, Protonix, AcipHex and Dexilant.