It has not ordered a recall of Zantac
The US Food and Drug Administration warned on Friday that a cancer-causing contaminant has been found in samples of some over-the-counter heartburn medicines like Zantac.
But while it has advised patients taking over-the-counter versions to consider switching to a different medication it has not issued a recall.
The New York Times reported that Zantac is a brand-name version of the drug sold by Sanofi, but generic versions are also widely sold. The FDA has not identified any specific products that were affected.
Sanofi says the company does not plan to recall the product. The over-the-counter version of Zantac “has been around for over a decade and meets all the specified safety requirements for use in the OTC market,” according to a statement issued by the company.
The contaminant, a type of nitrosamine called N-nitrosodimethylamine, or NDMA, is the same one found in some versions of valsartan, a blood-pressure drug carrying the brand name Diovan. The discovery of NDMA in valsartan led to several recalls of the drug.
Nitrosamines can cause tumors in the liver and other organs in lab animals and are believed to be carcinogenic in humans. NDMA can form during manufacturing if the chemical reactions used to make the drug are not carefully controlled and monitored, the FDA said.
But the publication noted that the levels of NDMA found in the drug were not high enough that the agency was recommending recalls. Low levels of NDMA are also found in other drugs and in food products.
The European Medicines Agency also said that it will start a review of ranitidine medicines after tests showed that some of these products contained an impurity called NDMA.