The Food and Drug Administration (FDA) is asking drug manufacturers to recall all heartburn medications that contain ranitidine, the active ingredient in Zantac and its generics, as well as another active ingredient from the same drug class, called nizatidine, in the prescription acid reflux drug reducer, Axid, if testing reveals they contain a probable cancer causing impurity called N-Nitrosodimethylamine, or NDMA.
The FDA has tested numerous heartburn medicines that contain ranitidine as well as other drugs in the same class, called H2 (histamine-2) blockers, since the agency announced on Sept. 13 that it was investigating whether ranitidine was contaminated with the possible cancer-causing impurity.
The same impurity was found last year in a class of high blood pressure and heart failure drugs known as angiotensin II receptor blockers, or ARBs. The discovery led to multiple recalls.
“We set out to fully understand this issue [in heartburn drugs] and provide actionable information for American who use these medications,” said Janet Woodcock, MD, FDA’s director for the Center for Drug Evaluation and Research. “The information we’ve gathered as part of our ongoing ranitidine investigation has been vital to answering the questions we’ve received about the potential risk of these products.”
The FDA said in its testing of ranitidine, it has found levels of NDMA in the drugs that are similar to the levels that are typically found in foods like grilled or smoked meats. However, some third-party scientists say they have found NDMA levels that exceed what the FDA considers acceptable. The agency conducted tests that simulate what happens to ranitidine after it has been exposed to acid in the stomach or small intestines, and found that NDMA is not formed through these processes. But to fully understand if ranitidine forms NDMA, the drugs must be tested in the human body.
“We are still working with manufacturers to investigate the true source of NDMA and to understand the root cause of the low levels of NDMA present in the drugs,” Woodcock said.
In the interim, the FDA maintains its recommendations for consumers taking over-the-counter ranitidine or nizatidine to consider using other OTC products approved for their condition. Testing on the H2 blocker and proton pump inhibitor (PPI) classes of heartburn drugs has identified NDMA only in ranitidine and nizatidine. But samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) show no NDMA impurities in the medicines. People taking prescription ranitidine or nizatidine should speak with their doctors about other treatment options, the FDA recommends.
“We know impurities in medicines are of great concern to patients and consumers who rely on safe and effective medicines approved by the FDA,” Woodcock said, “and we are working with manufacturers and global regulators to provide clear and actionable information.
Beasley Allen attorneys Frank Woodson and Matt Munson are actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, bladder or pancreas. If you or a loved one may have been affected, please contact us.