The US Food and Drug Administration (FDA) is calling on manufacturers to immediately remove from the market any and all prescription and over-the-counter (OTC) drugs containing ranitidine, used to treat and prevent heartburn. The move comes after months of growing concerns about contamination of such drugs with N-Nitrosodimethylamine (NDMA), a possible carcinogen.
Research has determined that the presence of NDMA becomes an issue in ranitidine-containing products when stored over time, especially when stored above room temperature. Under such conditions, the concentration of the contaminant could reach unacceptable, potentially dangerous levels.
According to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, the measure is more of a precautionary step rather than the removal of an imminent danger.
“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,” she said.
In mid-2019, the FDA was presented with independent laboratory findings that discovered NDMA in ranitidine. While low levels of the substance can be ingested safely in food and water, sustained higher levels of exposure could increase the risk of cancer.
Then, the agency conducted its own laboratory tests in ranitidine, finding NDMA contamination at low levels. In September 2019, FDA officials warned the public of the potential danger, advising them to consider halting use of ranitidine products and recommended use of alternative treatments.
In January, Emery Pharma filed a citizen petition urging the FDA to suspend sales of ranitidine products, due to the degradation risk.
This week’s recommended withdrawal of all ranitidine products comes after the agency’s own testing, as well as data from third-party laboratories, showing the increased presence of NDMA after prolonged storage and subjection to higher temperatures. These conditions, the agency determined, may raise the presence of NDMA above the acceptable daily intake limit.
The FDA has sent letters to manufacturers asking for withdrawal of their ranitidine products from the market. Additionally, the agency is advising consumers to switch to other approved OTC products if they wish to continue treatment.
The agency pointed out NDMA testing has not uncovered NDMA in other frequently used drugs, including famotidine, cimetidine, esomeprazole, lansoprazole or omeprazole.
In September, several retail chains (including CVS Pharmacy, Walgreens and Walmart) announced they would no longer sell ranitidine products in their stores. Also that month, Sandoz moved to recall all lots of ranitidine hydrochloride tablets from the US.
In October, Sanofi announced they would voluntarily recall all of its Zantac OTC products from US shelves.