A substance that would trigger cancer has been found in some ranitidine heartburn, and ulcer medicines, including the brand-name drug Zantac, and the supply of this contamination is being investigated, the U.S. Food and Drug Administration says.
While preliminary exams found low ranges of the nitrosamine impurity N-nitrosodimethylamine (NDMA) in some ranitidine products, the FDA stated this does not mean patients taking medicine should stop using them now.
NDMA is similar contaminant found in many manufacturers of blood pressure and heart failure medicines throughout the past year, leading to recalls.
Patients who are taking prescription ranitidine and need to cease using it should discuss alternate options with their health care provider, the FDA suggested. Those taking over-the-counter (OTC) ranitidine might switch to other OTC medicines.
Several drugs are authorized for the same or similar makes use of, the FDA noted.
NDMA is an environmental contaminant present in water and foods, together with meats, dairy products, and greens. It’s classified as a possible human carcinogen.
The FDA stated it is evaluating whether the low levels of NDMA in ranitidine pose a threat to patients and that it will put up that information when it is available.
Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, mentioned the FDA is working with international regulators and industry companions to find out where the contamination originated.
“The agency is analyzing ranges of NDMA in ranitidine and evaluating any potential danger to patients,” she stated in a news launch. “The FDA will take applicable measures based on the results of the ongoing investigation.”
Large amounts of NDMA could pose a danger, but the ranges of NDMA in ranitidine found in preliminary tests barely exceed amounts present in everyday foods, based on the FDA.