April 01, 2020
Thom Carroll/for PhillyVoice
The FDA has ordered all Zantac and other generic ranitidine medications to be removed from the market after finding levels of a probable carcinogen, N-nitrosodimethylamine (NDMA), can increase over time in the drug.
Zantac and all generic ranitidine medications are being taken off the market because they contain an impurity that may cause cancer.
The U.S. Food and Drug Administration ordered the removal after finding levels of the probable carcinogen, N-nitrosodimethylamine levels, can increase over time. As a result, people taking the medications could be exposed to unsafe levels of the impurity.
NDMA is an environmental contaminant found in water and foods, including meats, dairy products and vegetables, according to the FDA. It's not considered dangerous in small quantities, but higher levels of exposure could increase cancer risk.
The FDA first announced it was investigating the impurities in September. That led to some voluntary recalls of ranitidine products and prompted some pharmacies to remove them from their shelves.
The FDA found NMDA levels increased when ranitidine was stored under normal conditions. It significantly increased when the drug was kept at "higher than room temperature." Additionally, the longer the medicine was kept in storage, the higher the levels of the impurity.
The FDA did not find unacceptable levels in any of the samples they tested, but officials decided to remove the product from the market out of precaution. This includes over-the-counter and prescription medications.
"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,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
The FDA recommends that consumers who take over-the-counter ranitidine to stop using it altogether. For patients who still need heartburn relief, it recommends the following medications:
•Famotidine (Pepcid)
•Cimetidine (Tagamet)
•Esomeprazole (Nexium)
•Lansoprazole (Prevacid)
•Omeprazole (Prilosec)
Those that take prescription ranitidine are encouraged to talk to their doctor before switching to a new medication.
At this time, the FDA does not recommend patients dispose of their medications at drug take-back locations due to the coronavirus pandemic. Instead, officials recommend people place it in their trash at home. Here are some helpful tips on how to dispose of a medication.
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