Earlier this year, the drug valsartan was found to contain traces of N-nitrosodimethylamine (NDMA), a probable human carcinogen, due to a production change in 2012. The findings have already prompted recalls in more than 50 countries. Now, EMA is assessing the impact of a related substance, N-nitrosodiethylamine (NDEA), which has been detected in valsartan made by Zhejiang Huahai using its previous manufacturing process before changes were introduced in 2012. Further risk assessment had confirmed that the life-time risk of cancer from exposure to levels of NDMA detected in valsartan was considered low.
The FDA on Thursday announced that three lots of Torrent Pharmaceuticals’ valsartan drugs contain NDEA, which is known to cause cancer in animals and is thought to be another human carcinogen. However, If you take a valsartan drug for high blood pressure or heart failure, the FDA recommends you continue to take it until you can speak with your doctor or pharmacist. Not all valsartan drugs are involved in the recall, they might be able to switch you to a version of the drug made by another company.