On April 1, 2020, the Food and Drug Administration (FDA) recalled all over-the-counter ranitidine medicines. They are investigating the ingredient N-Nitrosodimethylamine (NDMA), a carcinogen that may be able to cause cancer when you are exposed to it in high enough doses, and the harmful effects it may have on Zantac users when the drug is stored improperly. The drug is most well-known by the name Zantac.
How much NDMA is in Zantac and how did the FDA discover it?
The FDA was unaware until a study was conducted by an independent laboratory in 2019 that revealed when the drug is stored somewhere higher than at room temperature an “impurity” increased exponentially over time and caused those taking the drug to be exposed to higher levels of the NDMA than is safe.
NDMA, though obviously dangerous at high dosages, is present in food and drink that we consume on a daily basis, where the levels remain low enough that they do not pose a threat to your health. However, as the levels of the potentially harmful ingredient increase when the drug is stored both at room temperature and above, as more studies revealed about the drug and its harmful ingredients, the FDA has seen fit to remove the drug from circulation within the United States.
Though the harmful ingredient was not present in every sample the FDA took, as it is unknown how long each sample had been stored, and at what temperature, a total recall on the drug was advised as a precautionary measure.
What has happened to the production and sale of Zantac?
As a popular over-the-counter drug to treat heartburn, Zantac could previously be found in most drug stores, including CVS, Walgreens, and Rite Aid. In addition, retail stores such as Walmart and Target, both of which have their own pharmacy section, also ceased the sale of the drug at the order of the FDA.
The mandate also means that the drug is also not available to be prescribed in the United States. Drug manufacturers have also been sent letters by the FDA that instruct them to stop making the drug and that they withdraw their product from retail stores.
What should you do if you have Zantac at home?
At the FDA’s guidance, it is suggested that those who have supplies of Zantac in their homes and are currently taking the medication stop immediately and properly dispose of what they have left. The FDA suggests speaking to your doctor about possible alternatives that do not have the same NDMA risks as Zantac. Some alternatives suggested by the FDA include:
- famotidine (Pepcid)
Ask your doctor before taking any of these medications to ensure that they are the right option for you.
The FDA has given specific guidelines on how to properly dispose of medicine that is no longer viable.