Since few months, many recalls of popular drug called valsartan have been occurred already. Now, the generic medicine manufacturer Mylan Pharma is going to add more such products to that list. This recall includes 104 lots of three types of medicines such as valsartan tablets, the combination of drug valsartan with amlodipine and combination of drug valsartan with hydrochlorothiazide. The main reason behind this move is somewhat similar to prior recalls of valsartan drugs that was due to the detection of cancer causing agents like N-nitrosodiethylamine with the valsartan medicines. NDEA is seen in some kind of food items, drinking water, industrial processes as well as air pollution.
The United State’s FDA is searching for the origin of such contaminants, which are linked with factories of India and China that help provide valsartan to the generic drug manufacturers. Such factories had some connection with the second type potential carcinogen, known as NDMA or N-nitrosodimethylamine. Valsartan helps in treating the patients having high blood pressures, heart failures and to decrease death risk after severe heart attack. The drug when combined with hydrochlorothiazide and amlodipine is used for treating high blood pressures.
The recall includes about 26 lots of valsartan and amlodipine, USP (5mg/160mg; 10mg/160mg; 5mg/320mg, as well as 10mg/320mg); 51 lots of valsartan tabs, USP (40mg, 80mg, 160mg and 320mg); and 27 lots of valsartan tablets and hydrochlorothiazide, USP (80mg/12.5mg; 160mg/12.5mg; 160mg/25mg; 320mg/12.5mg; and 320mg/25mg). These tablets were distributed across the US between March2017 and November2018. Janet Woodcock of FDA said, “We are unaware of the whole root cause for this problem yet. We don’t know the steps which led to the problem.” In addition to this, all the “sartan” drugs are being checked for any contamination, says Woodcock. So far, carcinogens haven’t been found in Diovan, which is the brand version of the valsartan manufactured by Novartis, Woodcock noted.
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