BOTH the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have issued updates on their evaluation of angiotensin-II-receptor antagonist valsartan products subsequent to the product recalls in Jul (PD 11 and 16 Jul) due to the presence of possibly carcinogenic impurities NDEA and NDMA.
The FDA has found additional potential carcinogenic impurities in three lots of Torren Pharmaceuticals recalled valsartan products.
Inspections of the supplier manufacturing facilities have generated new means of detecting impurities which manufacturers and regulatory agencies can use.
With risks associated with taking the products considered extremely low, the agencies have advised patients to continue with their medication until advised otherwise by their health professional.
The TGA has confirmed that no local supplies of valsartan products were affected (PD 09 Aug).
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