FDA asks for Zantac to be removed from market

WASHINGTON, D.C. – A popular over-the-counter heartburn medication may be dangerous, according to the federal government.

The U.S. Food and Drug Administration is asking manufacturers to withdraw Zantac from the market due to an impurity in the drug that can increase over time, especially when stored at high temperatures. The impurity, known as N-Nitrosodimethylamine (NDMA), has been identified as a probable human carcinogen, meaning it may cause cancer. While low levels of NDMA are commonly ingested, sustained higher levels of exposure were determined to present a potential risk.

As a result of the immediate market withdrawal request, the FDA said all ranitidine products will no longer be available in the United States.

“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. 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. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”

Testing did not show NDMA in other heartburn medications including famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).