FDA Pulls Heartburn Drug Zantac From Market
Withdrawal of ranitidine products means they will not be available either by prescription or OTC
WEDNESDAY, April 1, 2020 (HealthDay News) -- All versions of the heartburn drug Zantac (ranitidine) have been pulled from the U.S. market due to possible contamination with a probable human carcinogen, the U.S. Food and Drug Administration said Wednesday.
This is the latest step in an ongoing investigation of N-nitrosodimethylamine (NDMA) in ranitidine medications, the agency noted. In some ranitidine products, NDMA increases over time and when the drugs are stored at higher temperatures, which may result in people being exposed to unacceptable levels of the chemical, according to the FDA.
"With ranitidine, the NDMA does not appear to be formed during manufacturing, but instead appears over time in storage, especially when stored at higher than room temperature," Janet Woodcock, M.D., director of the FDA Center for Drug Evaluation and Research, said in an agency news briefing on Wednesday. Packaging or specific formulations of the drug might play a role, too. All of that means that the buildup of NDMA in stored Zantac "may be a fixable problem," Woodcock told reporters. "We're open to companies demonstrating that they've reformulated their product in a way that is stable."
The agency's order for immediate withdrawal of all ranitidine products means they will not be available either by prescription or over the counter (OTC) in the United States. Consumers taking OTC ranitidine should stop taking any tablets or liquid they have, dispose of them properly, and not buy more. Those who want to continue treating their condition should consider using other approved OTC products, the FDA recommended. Patients taking prescription ranitidine should talk with their health care provider about other treatment options before they stop taking the medicine. FDA tests have not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), or omeprazole (Prilosec).