FDA Finds “Unacceptable” Levels Of NDMA In Zantac, Even With More Forgiving Testing Methods

With consumers facing rising concerns about the risk of cancer from Zantac, federal regulators indicated this week that the levels of carcinogenic chemicals detected in the widely used heartburn drug are at “unacceptable” levels, even after using a more forgiving testing method.

On October 2, the FDA issued an update about the safety of Zantac and generic ranitidine, after prior warnings indicated that the online pharmacy Valisure found high levels of the chemical N-nitrosodimethylamine (NDMA) in certain versions of the heartburn drug.

NDMA detected in Zantac is a chemical byproduct, which the World Health Organization has described as “clearly carcinogenic.” Long-term exposure has been linked to reports of liver cancer, stomach cancer, esophageal cancer and other digestive tract cancers when the chemical was found in other pills.

Valisure reported that tablets of Zantac may contain 26,000 times the permissible daily intake limit set by the FDA for NDMA, which indicates that levels should not exceed 96 nanograms per day.

The findings triggered the pharmacy to file a citizen’s petition calling for a Zantac recall, and a number of pharmacies have pulled the popular heartburn drug off of store shelves. While the FDA issued a warning about the Zantac NDMA contamination on September 13, consumers still have not been told to stop taking the drugs and a nationwide recall has not been announced.

In this latest update, the FDA indicates that testing of Zantac appears to have been done with a method using a higher temperature as part of the test protocols, which caused the Zantac pills to shed very high levels of NDMA, making the results appear artificially high. However, the agency noted that even when it tested Zantac and generic ranitidine products at lower temperatures, the pills still produced levels of NDMA that are unacceptably high.

The federal regulators plan on continuing the testing and looking at other heartburn drugs, such as Prilosec and Nexium, to make comparisons.

“FDA will test ranitidine oral solution products and has begun testing samples of other H2 blockers and proton-pump inhibitors to help inform this ongoing investigation,” the update states. “To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine.”

NDMA has been a focus of FDA attention over the past year, after the chemical was detected in the various different generic blood pressure drugs last year, resulting in hundreds of valartan lawsuits brought by former users who indicate they developed liver cancer, colorectal cancer and other cancers following long term exposure to the tainted drug.

Investigations stemming from the valsartan recalls suggest that NDMA entered that blood pressure medication due to changes in the generic drug manufacturing process, which caused the chemical byproduct. However, the cancer risk with Zantac appears to be an inherent element of the medication, with reports suggesting that the active ingredient ranitidine is unstable, and creates NDMA as a byproduct in the body.

Zantac has been on the market since 1983, and was the first “blockbuster” drug to have sales surpass $1 billion per year.

Drug manufacturers already face several Zantac class action lawsuits filed in recent days. In addition, they are expected to face individual Zantac lawsuits filed by those who used the drug and were diagnosed with cancer.