Defense Health Agency officials on Monday advised military beneficiaries who take Zantac, also known as ranitidine, for heartburn, ulcers or gastroesophageal reflux disease, to speak with their doctors to switch prescriptions. Those using an over-the-counter version should stop taking it.
The announcement follows an order from the Food and Drug Administration to manufacturers April 1 to withdraw all prescription and over-the-counter ranitidine products amid concerns that an ingredient has been linked to cancer.
According to the FDA, an impurity in Zantac called N-nitrosodimethylamine, or NDMA, "increases over time, and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity."
NDMA, a chemical found in industrial and natural processes, is an environmental pollutant that is classified as a probable carcinogen by the Environmental Protection Agency.
Last September, several drug companies, including Novartis and Apotex, manufacturers of generic ranitidine, announced a voluntary recall of their products sold in the U.S., and drugstore chains CVS and Walgreens decided to pull Zantac and generic versions from their shelves.
Sanofi, makers of Zantac, issued a recall of its product three weeks later.
In the April 1 announcement, FDA officials said they did not observe unacceptable levels of NDMA in the samples of ranitidine they 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," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
DHA officials said patients should follow FDA advice, speaking with doctors before stopping prescription versions of the medication and disposing of all versions of the drug. The DHA manages Tricare.
"The FDA is advising 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," they wrote.
The Defense Department participates in a drug take-back program; however, the DoD recommended that consumers follow FDA guidance to dispose of unused medications rather than risk going to a take-back location during the COVID-19 pandemic.
To throw away medications, the FDA recommends:
- Mixing uncrushed pills or liquids with an unappealing substance, such as dirt, cat litter or used coffee grounds.
- Placing the mixture in a container, such as a sealable plastic bag.
- Throwing the container away in the trash.
- Removing all personal information on the prescription labels of empty medication bottles or packaging and recycling.
The FDA also asks patients to report any adverse reactions they experienced while taking the medication, by speaking to their health providers or reporting through the FDA's MedWatch Adverse Event Reporting program.