The European Medicines Agency (EMA) is expanding its review of contaminated valsartan products following the detection of the potential carcinogen N-nitrosodiethylamine (NDEA) in losartan produced by Hetero Labs in India.
As a result of the detection of this impurity by German authorities, the review will now include medicines containing candesartan, irbesartan, losartan and olmesartan.
Both NDEA and a related compound N-nitrosodimethylamine (NDMA) are classified as probable human carcinogens. How these impurities came to be present during the manufacture of sartans is yet to be fully established and is being evaluated in the ongoing review.
Based on the trace amounts of NDEA seen so far in one batch of losartan from Hetero Labs, the EMA says there is no immediate risk to patients. Further tests are required to determine the extent of the contamination and whether impurities are present in sartan medicines above levels that can be considered acceptable.
The review of valsartan was initiated by the EMA when unacceptable levels of NDMA were found in some products produced by a company in China. Subsequently a second contaminant (NDEA) was identified and a second manufacturer was added to the review. The EMA says the extension of the review to other sartans is a precautionary measure.