July 23, 2018
On Friday, July 13th, FDA announced the voluntary recall of several drugs containing the active ingredient valsartan. Valsartan is often used to treat serious medical conditions such as high blood pressure and heart failure. However, in early July, the European Medicines Agency (EMA) recalled several drugs containing valsartan due to impurity concerns. N-nitrosodimethylamine (NDMA), a probable human carcinogen, was found in the recalled products.
According to a recent statement from the FDA, “the presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured. The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.”
FDA has recalled five valsartan-containing medications:
However, it is important to note that not all products containing valsartan have been recalled. At this time, only valsartan supplied by Zhejiang Huahai Pharmaceuticals is being recalled. An updated list of FDA drug recalls can be found here.
In the FDA’s July 13th news release includes information for patients and healthcare providers who use or provide valsartan-containing medication. According to the statement:
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