Some brands of high blood pressure medication VALSARTAN are being recalled
The FDA has alerted doctors and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to trace amounts of an impurity, N-nitrosodimethylamine (NDMA), has been found in some products. NDMA has been found to be a cancer causing substance, based on results from laboratory tests.
Not all valsartan-containing medications are affected and being recalled. The finding of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.
As part of the FDA investigation, they will be looking at the levels of NDMA in the recalled products, assessing the possible impact 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.
The FDA suggests that because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product. Patients should contact their medical provider or pharmacist to discuss options for replacement.
One of the pharmaceutical companies recalling their products, Prinston Pharmaceutical Inc., says they have not received any reports of adverse events related to this recall.
A list of the pharmaceutical companies involved with the voluntary recall can be found here.