The European Medicines Agency (EMA) human medicines committee (CHMP) confirmed its recommendation to the European Commission to remove the heartburn drug Zantac and other acid blockers that contain the active ingredient ranitidine from the European Union (EU) because they pose health risks to consumers.
The European Commission had asked the CHMP to conduct a re-examination of Zantac after several ranitidine products were found to contain unsafe levels of a likely human carcinogen known as NDMA, short for N-nitrosodimethylamine. The EMA suspended sales of the drug on June 26.
The CHMP’s opinion will be forwarded to the European Commission, which will issue a final decision for the entirety of the EU.
The U.S. Food and Drug Administration (FDA) pulled the drugs from the United States market in April, after finding that NDMA could increase to unsafe levels under typical storage conditions, such as when exposed to heat or the longer it was from its manufacture date. Health Canada followed suit just last week, pulling all Zantac products from the Canadian market. The withdrawals in both countries were preceded by numerous recalls of ranitidine-containing products.
NDMA is an environmental contaminant that is present in some foods and water supplies. It is not considered to be harmful to humans at low levels. But sustained exposure at higher levels has resulted in cancerous tumors in laboratory animals.