THURSDAY, Sept. 19, 2019 (HealthDay News) — Novartis, the maker of a generic form of the popular heartburn drug Zantac, said Wednesday it will cease distribution of the medicine after investigations suggested that generic and branded versions contain a known carcinogen.
A distribution halt is not the same as a full recall, and it means that generic Zantac (ranitidine) remaining on store shelves can still be sold, CBS News reported.
The move stems from an announcement made last Friday by the U.S. Food and Drug Administration. In a statement, the agency said that a substance that could cause cancer had been found in some ranitidine heartburn and ulcer medicines, including the brand name drug Zantac, and the source of this contamination is being investigated.
Sanofi, the maker of Zantac, said in a statement on Wednesday that “there are currently no plans to stop distributing or manufacturing Zantac or other ranitidine products outside of Canada,” and added that “we are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards.”
While preliminary tests found low levels of the nitrosamine impurity N-nitrosodimethylamine (NDMA) in some ranitidine products, the FDA said last week that this does not mean patients taking the drugs should now stop using them.
NDMA is the same contaminant found in many brands of blood pressure and heart failure medications during the past year, leading to recalls.
Patients who are taking prescription ranitidine who want to stop using it should discuss alternatives with their health care provider, the FDA advised. Those taking over-the-counter (OTC) ranitidine could switch to other OTC heartburn medicines.
Several drugs are approved for the same or similar uses, the FDA noted.
NDMA is an environmental contaminant found in water and foods, including meats, dairy products and vegetables. It is classified as a probable human carcinogen.
“Drug impurities remain a major national concern,” said Dr. David Robbins, associate chief of endoscopy at Lenox Hill Hospital in New York City. “While Zantac may prove safe in the long run, this latest statement adds confusion and concern, so my interim advice to patients is simple: switch to another drug … and of course, confirm with your doctor the need for an antacid.”