Valsartan was a world’s number one selling high blood pressure drug .The patents for valsartan and valsartan/hydrochlorothiazide expired in September 2012. The drug is a very good target for the generic industries after patent expiry. However, in July 2018 Drug was recalled due to impurities by various countries including USA and Europe. This recall was due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. Later on during review another compound N-nitrosodiethylamine (NDEA) discovered in losartan. NDMA, NDEA are classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA, NDEA was unexpected still evaluated how they present in drugs.
Earlier most of time pharmacovigilance based the nature of the molecule however this ban also widened our horizon for the impurities that can cause harmful effect. Article discussed in details about the impurities presence and role of physician for drug safety.
