Preliminary tests revealed low levels of the nitrosamine impurity NDMA in some ranitidine products
THURSDAY, Sept. 19, 2019 (HealthDay News) -- Novartis, the maker of a generic form of 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.
According to CBS, 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, "[W]e 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 it does not mean patients taking the drugs should now stop using them. NDMA is the same contaminant that was found in many brands of blood pressure and heart failure medications during the past year that led to recalls. Large amounts of NDMA may pose a risk, but the levels of NDMA found in ranitidine in preliminary tests barely exceed amounts found in common foods, according to the FDA. The agency added that it is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients and that it will post that information when it is available.
CBS News Article
More Information: FDA