WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) is requesting that manufacturers immediately pull all prescription and over-the-counter (OTC) ranitidine drugs from the market.
The heartburn drugs, best known by the brand name Zantac, are widely used to treat stomach acid and ulcers.
Companies have recalled dozens of lots of Zantac and related drugs due to the issue. And the FDA previously said patients could continue taking the drugs because the risk was low.
However, regulators said Wednesday that levels of the chemical increase over time, especially when the drugs are stored at higher temperatures.
“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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
NDMA is a substance that could cause cancer. In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine.
Low levels of NDMA are commonly ingested in the diet. Those low levels would not be expected to lead to an increase in the risk of cancer. However, the FDA says sustained higher levels of exposure may increase the risk of cancer in humans.
“New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers,” wrote the FDA. “The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”
The FDA is also 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 OTC products.
The FDA says those taking prescription ranitidine should speak with their healthcare professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
In light of the current COVID-19 pandemic, the FDA recommends 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
which include ways to safely dispose of these medications at home.