FDA Finally Pulls Zantac

Washington, DCSince at least last summer the FDA has known that a contaminant known as N-Nitrosodimethylamine (NDMA) was present in ranitidine medications (commonly known as the brand name Zantac), but the agency didn’t order a withdrawal of the popular heartburn drug until this month – almost a year later. Chances are, countless people who have been taking a side of a potential carcinogen with their Zantac dose each day are concerned about the possibility of developing Zantac-related cancer —and many people are filing Zantac lawsuits.

The FDA issued a voluntary recall of Zantac last September for all retailers and consumers to return or destroy Zantac as “a precautionary measure” due to “inconsistencies in preliminary test results of the active ingredient” (meaning NDMA) in the US products. Several drug companies, including Novartis and Apotex, manufacturers of generic ranitidine, voluntarily recalled their products sold in the U.S., and drugstore chains CVS and Walgreens decided to pull Zantac and generic versions from their shelves. Sanofi, the maker of Zantac, issued a recall of its product three weeks later.

Then on April 1 the FDA ordered manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine products amid growing concerns that NDMA has been linked to cancer. Because of this action, all ranitidine products will no longer be available for new or existing prescriptions or OTC use in the U.S.

“Consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved over-the-counter products," the FDA stated in its press release.

The FDA now says that NDMA "increases over time, and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity." The Environmental Protection Agency has classified NDMA, which is a chemical found in industrial and natural processes, as a probable carcinogen. While the FDA “became aware” in the summer of 2019 that independent laboratory testing had found NDMA in ranitidine, the agency did its own testing and determined that the levels were low enough not to lead to an increase in the risk of cancer.

(That independent laboratory was the small pharmacy Valisure, which alerted the FDA in June 2019 about high levels of NDMA in ranitidine medications. In a citizen petition to the FDA in September, Valisure said it found “extremely high levels of [NDMA] ... in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.” The petition states that Valisure detected levels greater than three million nanograms per tablet—far exceeding the FDA’s daily limit of 96 nanograms.)

According to the FDA, its “new testing and evaluation prompted by information from third-party laboratories” indeed found that NDMA levels increase in ranitidine stored at higher temperatures and it increased even under normal storage conditions. Further, the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These results are most troublesome when considering how many people take medications past their expiry date or beyond their shelf life.
“These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit,” said the FDA. Has an acceptable daily intake of carcinogen been determined?