The problem was discovered when the European Medicines Agency (EMA) routinely tested batches of valsartan's active pharmaceutical ingredient (API) finding those from the supplier, Zhejiang Huahai Pharmaceuticals in Linhai in China to contain impurity. This impurity has the potential to cause cancer in humans. Simultaneously, the administration also suspended the use of Valsartan in producing medicines and is conducting research on the use and impact of Valsartan to ensure patients' safety and follow the procedures for changing drug registration dossiers as regulated. Provincial departments of health are responsible for notifying medical facilities and pharmacies about the withdrawal and announcing it on their websites.
Drugs for high blood pressure sit on the shelf of a pharmacy in Seoul on Monday. The drug regulator for the European Union said it would conduct an assessment of the severity of the problem for those who are now taking drugs containing Valsartan.More news: What President Trump said about May, Brexit, and 'England'
"Despite the lack of conclusive evidence on whether NDMA is present in these products or whether they are truly risky, these measures were undertaken to pre-emptively protect consumers", a spokesman for the Ministry of Food and Drug Safety said on Saturday. Of 484,682 kilograms of Valsartan imported over the last three years, only 13,770 kilograms, or 2.8 percent contain ingredients from China. The 219 drugs containing Chinese-made Valsartan are among 571 available drugs in Korea that contain the ingredient coming from other countries.
Several heart and high blood pressure drugs that contain valsartan are being recalled because of a substance that can cause cancer. It initiated on-site investigations of 82 companies to check whether the drugs contain NDMA.More news: Donald Trump ready to help some North Atlantic Treaty Organisation states buy USA arms
"It is vital that patients taking valsartan medication affected by this recall do not stop taking their medication abruptly and consult with their doctor or healthcare professional as soon as possible for alternative treatment", according to the Inspectorate of Health.More news: World Cup marred by "significant" sexism outside the stadium