The decision was taken after active pharmaceutical ingredient (API) manufacturer Zhejiang Huahai notified the European Medicines Agency (EMA) it had detected an impurity in its production of valsartan. The offending impurity is N-nitrosodimethylamine (NDMA), which has been listed as a probable carcinogen by the International Agency for Research on Cancer.
Valsartan-based medicine is used to treat patients with high blood pressure, it is also used in those patients who have had a heart failure or a recent heart attack.
The products are sold globally, which has led to a worldwide recall on a country-by-country basis. Products have been recalled from a number of European countries, while certain national authorities, including in Hong Kong, Taiwan and Canada, have also issued recalls.
Explaining how the NDMA may have been introduced into the active substance, the EMA suggested it was likely to have been introduced due to changes in the way the ingredient was manufactured.
The next step for the EMA is to conduct a review of the situation, including determining the levels of NDMA in the products, understanding how this may have affected patients and planning methods to eliminate or reduce such contamination in the future.
Novartis had brought valsartan to market but loss of exclusivity on the blockbuster led to the company scaling down its manufacturing operations for the drug. Now, the market has a number of generic alternatives, produced by companies such as Actavis and Stada, though only medicines with ingredients provided by Zhejiang Huahai will be recalled.
Zhejiang Huahai did not respond to a request for comment prior to publication.