En español | People who take the over-the-counter heartburn drug Zantac (ranitidine) should stop using it because of growing concerns that it contains a possible cancer-causing contaminant, the Food and Drug Administration (FDA) said on Wednesday. The agency suggests that patients with a ranitidine prescription should check with their health care provider before stopping treatment.
The FDA is also calling on manufacturers to withdraw all prescription and over-the-counter ranitidine drugs from the market immediately. Several drug chains took ranitidine products off their shelves last fall after the FDA alerted the public to the presence of the contaminant; some manufacturers issued recalls. The FDA's latest announcement goes one step further: It means the medications will not be available for new or existing prescriptions or over-the-counter use in the U.S.
As part of the investigation that started last summer, the FDA said it determined the contaminant in question (N-nitrosodimethylamine, or NDMA) increases over time in some ranitidine products, and when the medication is stored at higher-than-normal temperatures, consumers may be exposed to “unacceptable levels of this impurity.”
Humans frequently ingest low levels of NDMA, since it is found in foods and in water. Sustained higher levels of exposure, however, may increase the risk of cancer, according to the FDA. The agency's investigation found that, under certain conditions, the level of NDMA in some ranitidine samples was above the acceptable daily intake limit.
"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, director of the FDA's Center for Drug Evaluation and Research, said in a statement. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern."
In light of the current coronavirus pandemic, the FDA is asking people to follow disposal instructions in the medication guide or package insert, and not to take their ranitidine medications to a drug take-back center or pharmacy. The FDA also has advice on how to safely dispose of medicine at home.
A number of heartburn medications approved for the same or similar uses as ranitidine do not carry the same risks from NDMA, the FDA says. To date, government testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).