Singapore halts sales of some antacids over stomach cancer concerns
- The sale and supply of eight brands of the drugs were suspended after they were found to contain an impurity called NDMA, a potential carcinogen
Sale and supply of eight brands of the drugs were suspended after they were found to contain an impurity called NDMA that has been linked to cancer, Singapore’s Health Sciences Authority said on Monday in a statement. Levels of the substance exceeded the internationally accepted rate, it said.
Health regulators raised the alarm about the drugs on Friday. The US Food and Drug Administration and the European Medicines Agency each said they were investigating levels of NDMA in the treatments for heartburn and other gastrointestinal disorders. The class of drugs, whose active ingredient is called ranitidine, includes Sanofi’s Zantac and its generic copies.
Singapore officials said they are “working with the companies supplying these medicines and international regulatory agencies to verify the causes of the contamination, and to identify the necessary measures to address the issue”.
NDMA, or N-Nitrosodimethylamine, has been deemed a likely human carcinogen. It can be found in cooked or cured meats such as bacon and is a common industrial by-product. The same chemical has been found in high levels in dozens of versions of a hypertension treatment called valsartan, and many have been recalled.
Paris-based Sanofi said in an email that it takes patient safety seriously and is committed to working with the FDA and other health regulators. Zantac meets all safety requirements for the market, it said.
