The carcinogen found in the heartburn medication ranitidine, the active ingredient in the brand-name drug Zantac and its generic equivalents, is a “different problem” from the same carcinogen that arose in high blood pressure and heart failure drugs last year, Janet Woodcock, director of the Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research told the House Committee on Energy and Commerce last month.
The contamination of the impurity NDMA, a probable carcinogen, in a type of heart drugs known as ARBs last year is thought to have been caused by manufacturing flaw that caused the contamination. But the FDA’s chemists believe the NDMA in ranitidine “is formed by the molecule ranitidine reacting with something, either during the manufacturing synthesis or during the finished dosage form or during storage,” Woodcock said.
The FDA tried to determine if the drug reacted with stomach acids or fluids in the intestines, but didn’t find evidence of an NDMA-causing reaction. The agency said that it would need to study the drug in humans to better determine if that is the cause.
The issue with the popular acid-reducer – available over-the-counter as well as by prescription – was identified by Valisure, a Connecticut-based online pharmacy and laboratory. Valisure tested ranitidine in stomach-acid like fluids along with nitrates, which are chemicals often found in processed foods like hot dogs, and found that the NDMA levels in one dose of ranitidine was more than 3,100 times higher than what the FDA considers an acceptable daily threshold of NDMA.
The company notified the FDA, which led the agency to conduct its own testing on about 1,500 samples of ranitidine in which it found “low levels” of the probable carcinogen. About a half dozen companies issued recalls on their ranitidine-containing products.
“This isn’t some new, bad manufacturing process overseas like what happened with valsartan and losartan. It’s our view that this problem with ranitidine has been there since the 1980s,” said Valisure CEO David Light. “It’s a much more serious issue.”
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.