On Thursday, the U.S. Food and Drug Administration (FDA) made a serious push to stop using a very popular antacid that's available throughout pharmacies in the country. According to a new FDA warning, manufacturers are being urged to immediately discontinue all prescription and over-the-counter ranitidine medications, known by the brand name Zantac. The agency noted that an ongoing investigation has determined the contaminant called N-Nitrosodimethylamine (NDMA), found in ranitidine medications, can lead to cancer.
NDMA levels in ranitidine medications have been under FDA investigation since the summer of 2019. According to the FDA, the levels of NDMA in Zantac can increase over time if the product is stored at higher-than-normal room temperatures, which then poses a public health risk to consumers.
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said in a statement. “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.”
The investigation was prompted by the online pharmacy Valisure, which said its own tests revealed high levels of the contaminant, The New York Times reported. As such, the pharmacy petitioned the FDA to request a recall of all products containing ranitidine.
David Light, a founder and chief executive of Valisure told the Times the online pharmacy is still researching the long term effects of taking Zantac and other drugs containing ranitidine on consumers. “That remains very concerning to us,” he said.
To date, the FDA has not found NDMA in other similar products, such as Pepcid, Prevacid, Tagamet, or Prilosec, according to its testing. The agency says it will continue its “ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and will continue to work with drug manufacturers to ensure safe, effective and high-quality drugs for the American public.”
The FDA says that consumers should not return the drug to a “drug take-back location” at this time, due to the ongoing coronavirus pandemic. Instead, they recommended that anyone taking over-the-counter forms of the medication stop taking them and dispose of them properly based on the instructions provided on the medication guide or insert.
As for people who are prescribed the drug, they should check with their doctors about other safer medication options before stopping treatment.