EMA update on review of recalled valsartan medicines

Following action last month by both European and US regulators after the discovery of an impurity in certain medicines containing the blood pressure drug valsartan, the European Medicines Agency has issued its preliminary assessment of possible risks to patients.

The EMA says it is conducting a review of the possible health effects in patients who may have taken valsartan medicines containing N-nitrosodimethylamine (NDMA) – an impurity found in the active substance manufactured by Chinese firm Zhejiang Huahai Pharmaceuticals.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on animal tests. It is present in some foods and water supplies but is not expected to cause harm when ingested in very low levels.