Zantac Does Not Turn Into NDMA In Stomach, But Levels Exceeding Safety Limits Still Present: FDA

Amid continuing concerns about the cancer risk from Zantac, federal health officials are attempting to calm public fears, indicating that the active ingredient in the widely used heartburn drug does not transform into as high levels of N-Nitrosodimethylamine (NDMA) in the stomach as some experts have indicated, but the levels of the chemical produced by the drug are still often excessive.

In a statement issued on Friday, the director of the FDA Center for Drug Evaluation and Research, Dr. Janet Woodcock, indicated that the agency has confirmed levels of the cancer-causing agent NDMA in Zantac and generic ranitidine that exceed the FDA daily permissible limit in some pills. However, she said the agency’s own laboratory tests has not found that ranitidine in Zantac is converted into NDMA in the stomach, and said the levels of NDMA are finding are comparable to what is found in some grilled and smoked meats.

The findings partially confirm and contradict those of the independent pharmacy Valisure, which has filed a citizen petition calling for a Zantac recall, after its own independent testing, and the findings of a number of studies by researchers from Stanford University, suggest that Zantac could release levels of NDMA that are 29,000 times higher than the FDA’s permissible daily limit of 96 ng.

Woodcock indicates the FDA has conducted simulations designed to replicate what happens to ranitidine when exposed to stomach acid and the small intestines along with a normal diet. However, she admitted the FDA had not yet actually tested the drugs in the human body.

The statement also does not clarify what the agency considers a “normal diet”, as the Valisure testing found massive amounts of NDMA at levels intended to replicate a diet high in nitrites. The independent pharmacy testing identified and modeled an enzyme known as DDAH-1, which appears to be the mechanism in the body which converts ranitidine into millions of nanograms of NDMA. In addition, several years ago, Stanford University researchers released findings of a human study that suggests Zantac 150 once a day may result in excess of 40,000 ng of NDMA in the urine.

Zantac Recalls Justified, FDA Finds

While the FDA statement indicates the levels of NDMA in Zantac found by Valisure were not confirmed by this latest testing, Woodcock does indicate the findings validate the levels are high enough to justify the recent spate of recalls issued for Zantac and generic ranitidine tablets by a number of different drug makers.

“Although many of these levels of NDMA observed through FDA testing are much lower than the levels of some third-party scientists first claimed, some levels still exceed what the FDA considers acceptable for these medicines,” Woodcock wrote. “If we or the manufacturers find NDMA levels above the acceptable limits, we’re now asking companies to voluntarily recall ranitidine.”

Woodcock also revealed that the FDA’s testing found excessive levels of NDMA in a similar heartburn drug, Axid (nizatidine), and is requesting manufacturers of the formulations which were found to contain excessive NDMA voluntarily recall the drug from the market.

The FDA recommends consumers switch from Zantac to other alternative heartburn treatments, which have not tested positive for high NDMA levels, including Nexium, Prilosec, Pepcid and other options To date, testing has only found high levels of NDMA in Zantac, Axid and their generic equivalents.

The Zantac cancer risk was first publicly disclosed in the U.S. in September, after Valisure announced the findings of their test results and called on federal regulators to remove the drug from the market. The group also urged the FDA to provide instructions to consumers about the safe disposal of the medication to avoid widespread water contamination, and sent a copy of the petition to the World Health Organization, indicating that Zantac should be considered a human carcinogen.

The FDA first warned about the Zantac problems on September 13, indicating several different versions of the heartburn drug have been found to contain the impurity, which could cause cancer. As a result, major retailers have removed Zantac from store shelves, and nearly every version of the medication has now been recalled.

While drug makers and federal regulators indicate they are continuing to investigate Zantac NDMA contamination, many consumers are now questioning whether they may have avoided a cancer diagnosis if other available alternative treatments for heartburn had been used.

A growing number of Zantac lawsuits are now being pursued by individuals diagnosed with bladder cancer, stomach cancer, small intestine cancer, colorectal cancer, esophageal cancer and other problems impacting the digestive tract as NDMA from ranitidine moved through the body.