Some drugs to treat and prevent heartburn may contain traces of human carcinogens, according to a Sept. 13 warning from the FDA.
Specifically, the FDA announced some ranitidine medicines, including the brand name Zantac, contain low levels of a nitrosamine impurity, N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen that could cause cancer. NDMA, a contaminant, has been found in water and foods, such as meats, dairy products and vegetables.
The FDA has been looking into the presence of NDMA in heartburn medications since last year, issuing numerous recalls as the agency found “unacceptable levels of nitrosamines.” And the agency is now investigating if low levels of NDMA are risky to patients, but the FDA has not yet announced people should stop taking these heartburn medications. The FDA does recommend reporting any adverse reactions to ranitidine to its MedWatch program.
“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 risk to their health,” the agency’s announcement reads. “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.”
Patients who want to stop taking ranitidine are urged to talk with their healthcare professional for another option, the FDA noted. And those who take over-the-counter ranitidine should consider other medications to manage their condition.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."