The European Medicines Agency on Thursday (August 2nd) revealed that there are impurities in a molecule made in China, valsartan, that could cause cancer cases in Europe.
The impurities contained in a molecule manufactured in China for the pharmaceutical industry, valsartan, will cause cancer cases in Europe , warned Thursday, August 2, the European Medicines Agency (EMA). The problem comes from valsartan, the active ingredient in cardiology drugs (heart failure, high blood pressure, recent cardiac infarction).
On July 18, the Chinese laboratory Huahai recalled the molecule worldwide, because of the presence of N-nitrosodimethylamine (NDMA), a substance classified as probably carcinogenic to humans in case of prolonged use.
“Based on a preliminary assessment, the EMA estimates that there could be an additional case of cancer among 5,000 patients taking the affected drugs at the highest dose of valsartan (320 mg) each day for seven years” , the European agency wrote in a statement.
Waiting for analyzes
The EMA has indicated that it does not know how many patients this would be because it is waiting for analyzes to determine the concentration of NDMA in the drugs in question. For the moment, she said she relies on “the average levels of this impurity detected in the active ingredient by Zhejiang Huahai Pharmaceuticals (60 parts per million)” and on “animal studies” .
In addition, since the molecule was withdrawn from the market, the EMA insisted that patients continue their treatment. “It is important to note that there is no immediate risk for patients. Those who take the medications that are affected and have not yet gone to another should not stop taking their medication without consulting their doctor or pharmacist, ” she said.
European authorities believe that the impurity “was introduced as a secondary product after changes made by Zhejiang Huahai in its industrial process in 2012,” said the EMA.