EMA Broadens Valsartan Contamination Investigation

The EMA expanded its investigation of valsartan impurities after a new contaminant was discovered in an Indian manufacturer’s active substance, losartan.

The EMA found low levels of N-nitrosodiethylamine (NDEA) — an organic compound in tobacco smoke — in losartan, an active substance manufactured by Hetero Labs. The agency announced that it will expand its review of impurities in valsartan to include four other blood pressure products — candesartan, irbesartan, losartan and olmesartan.

The EMA called the extension of the review to other sartans “precautionary” and said it’s working with national authorities, international partners and the European Directorate for the Quality of Medicines to “gather data on these medicines as quickly as possible.”