Overall reminder of a medicine for the heart due to potential contamination with a carcinogen

The decision was made after the manufacturer of the active pharmaceutical ingredient (API) Zhejiang Hauhai notified the European Medicines Agency (EMA) that she had detected an impurity in her production of valsartan. The incriminated impurity is N-nitrosodimethylamine (NDMA), which has been classified as a probable carcinogen by the International Agency for Research on Cancer.

Valsartan medicine is used to treat patients with high blood pressure. in patients who have had heart failure or a recent heart attack.

The products are sold worldwide, which has led to a worldwide recall country by country. Products have been recalled from a number of European countries, while some national authorities, including Hong Kong, Taiwan and Canada, have also issued recalls.

Explaining how NDMA could be introduced into the active ingredient, the EMA The next step for the EMA is to conduct a review of the situation, including determination of NDMA levels in the products, understand how this may have Novartis had introduced valsartan to the market, but the loss of exclusivity on the blockbuster has led the company to reduce its manufacturing activities for the drug. Now the market has a number of generic alternatives, produced by companies like Actavis and Stada, although only drugs with ingredients provided by Zhejiang Huahai will be recalled.