The FDA announced Sept. 13 it identified low levels of N-nitrosodimethylamine, or NDMA, in popular heartburn drugs including Zantac.
The larger class of medications, known as ranitidines—histamine-2 blockers that can be sold over-the-counter or prescribed to relieve heartburn and acid reflux—are just the latest in a slew of CV drugs found to contain NDMA after FDA review. For more than a year now, common blood pressure and heart failure drugs including valsartan, losartan and irbesartan have faced recalls due to the presence of trace amounts of probable human carcinogens, including NDMA.
In a statement penned by Center for Drug Evaluation and Research Director Janet Woodcock, MD, and released to the public, the FDA said it wasn’t recommending patients stop taking ranitidine at this time, but if people are concerned they can opt for another OTC heartburn drug or chat with their doctors about a prescription alternative.
“Patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risks to their health,” Woodcock wrote. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”
The agency said it’s currently working with international regulators and industry stakeholders to find the root cause of NDMA impurities in ranitidine products. It assured the public it would “take appropriate measures based on the results of the ongoing investigation” and provide updates as more information becomes available.
For now, the FDA asks consumers and healthcare professionals to report any adverse reactions to ranitidine to the agency’s MedWatch program.
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.