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The U.S. Food and Drug Administration (FDA) is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately, it announced today. 


 

“This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac),” the FDA said. “The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.”

 

As a result of the immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S., according to the FDA. 

 

NDMA is a probable human carcinogen, a substance that could cause cancer, according to the FDA.  “Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water,” the FDA said. “These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans.”


 

Due to the COVID-19 pandemic, the FDA is recommending patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home.

 

More information on the FDA’s investigation can be found here.