Zantac Cancer Exposure Similar To Eating ‘Grilled Or Smoked Meats’, FDA Says

Following the recall for over-the-counter and prescription ranitidine heartburn medications, because they may contain cancer-causing ingredients, the U.S. Food & Drug Administration (FDA) has released its findings of initial testing on the products.

The FDA said it is investigating the medications for the contaminant N-Nitrosodimethylamine (NDMA), which it has found in ranitidine medications often referred to as Zantac. The FDA said it tested numerous ranitidine products over the last few months and has found levels of NDMA that are similar to exposure to common foods such as “grilled or smoked meats.”

According to the FDA, “The information we’ve gathered as part of our ongoing ranitidine investigation has been vital to answering the questions we’ve received about the potential risk of these products.”

The agency also tested the ranitidine medication to understand exposure to acid in the stomach with a normal diet and found that NDMA is not formed during this bodily process. The FDA also found that NDMA is not formed in a “stimulated small intestine environment” but said it needs to continue testing to understand if ranitidine forms NDMA.

However, the FDA did say, “many of these levels of NDMA observed through FDA testing are much lower than the levels some third-party scientists first claimed, some levels still exceed what the FDA considers acceptable for these medicines.”

After its findings, the FDA is asking manufacturers to voluntarily recall ranitidine as well as nizatidine, also known as Axid, if NDMA level is above the acceptable daily limit of 96 nanograms per day or 0.32 ppm is found. The FDA is also asking manufacturers to conduct their own testing of NDMA levels.

“In the meantime, our recommendations for consumers and patients have not changed,” the FDA said. “Consumers taking OTC ranitidine or nizatidine can consider using other OTC products approved for their condition.”

The FDA recommends alternative products such as Pepcid, Tagamet, Nexium, Prevacid, and Prilosec, as they have not shown any NDMA impurities in their medication formulation. Those taking prescription ranitidine or nizatidine medications should contact their healthcare provider for other treatment options.