FDA Wants All Ranitidine Products Off the Market

— Finds levels of probable carcinogen increase during storage

https://www.medpagetoday.com/gastroenterology/generalgastroenterology/85740

WASHINGTON — All ranitidine products should be pulled from shelves immediately, the FDA said Wednesday, including brand-name Zantac as well as generic versions of the prescription and over-the-counter antacid.

Notably, this was not because of direct evidence of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, being present in particularly high concentrations in the drug itself.

“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity,” according to the FDA announcement.

Reports of NDMA impurities in ranitidine began in the summer of 2019, following similar discoveries in generic angiotensin receptor blockers.

Now, the FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The agency is also advising consumers to stop buying and taking over-the-counter ranitidine. Those who wish to continue treatment to relieve gastroesophageal reflux and for gastric and intestinal ulcer prevention should consider using other approved products, the FDA said.

Filed under: General Problems