Carcinogen in Zantac, generics triggers FDA, EU investigates

Bloomberg

Global health regulators sounded a coordinated alarm about the possibility that a stomach drug taken by millions of people could be tainted with the same cancer-causing agent that has sparked a worldwide recall of blood-pressure pills.
Drug-safety officials in the US and Europe said that they were looking into whether Sanofi heartburn medication Zantac and generic versions made by numerous manufacturers contain levels of the probable carcinogen NDMA that could pose a danger to patients.
Ranitidine, as the drug is known in generic form, is an antacid and antihistamine used to treat and prevent a range of gastrointestinal disorders.
The chemical NDMA (N-Nitrosodimethylamine) is a likely human carcinogen found in cooked or cured meats such as bacon, and is a common industrial byproduct.
The discovery further underscores the challenge pharmaceutical-industry regulators face in overseeing a vast global supply chain of drugs, drug ingredients and factory processes.
Dozens of versions of the hypertension treatment valsartan have been recalled since last year out of concern they could be contaminated with NDMA.
Many of those drugs were made in China or India, raising questions about the quality of generic manufacturing in far-flung factories around the globe. Bloomberg News has reported on how poor quality controls and efforts to conceal manufacturing problems from the FDA have complicated oversight of overseas drug producers.
The review of ranitidine comes after Valisure, a New Haven, Connecticut-based online pharmacy that tests all the medications it dispenses, alerted the US Food and Drug Administration that it had detected high levels of NDMA in both generic and brand versions of Zantac sold at major pharmacies run by companies including Walgreens Boots Alliance Inc, CVS Health Corp and Walmart Inc.
The FDA said in a statement it would review branded and generic versions of the medication. The European Medicines Agency said it “is evaluating the data to assess whether patients using ranitidine are at any risk from NDMA and will provide information about this as soon as it is available.”
Sanofi officials didn’t comment immediately when reached by phone.
The FDA detected NDMA in both prescription and over-the-counter versions of Zantac but hasn’t collected enough samples to give a range of carcinogen levels found, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said in an interview. FDA and European regulators use different testing methods than Valisure, she said, but declined to give details.
Valisure filed a petition with the FDA asking the agency to recall Zantac and its generics that contain NDMA. The FDA said the NDMA levels in the drugs are low, while Valisure’s petition called them “excessive.”