The European Medicines Agency (EMA) has launched a review of valsartan-containing products after the carcinogen N-nitrosodimethylamine (NDMA) was detected in the valsartan active substance manufactured by Zhejiang Huahai Pharmaceuticals.
NDMA is a by-product of several industrial processes and is known to be toxic to the liver and other organs and is classified as a probable human carcinogen. It is also often used to induce cancer in rats for cancer research.
While the review is ongoing, products potentially containing the contaminated active substance are being recalled across Europe. National authorities are contacting pharmacists with information on the medicines to be recalled.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) is investigating the levels of NDMA in affected products and the possible impact on patients who have been taking these medicines as well as what measures can be taken to reduce or eliminate the impurity from future batches produced by the company. The investigation will also consider whether other valsartan medicines may be affected.
Following the review, the CHMP opinion will be forwarded to the European Commission, which will issue a final legally-binding decision which will be applicable to all EU Member States.