VILNIUS – Lithuania's State Medicines Control Agency is recalling all batches of valsartan-containing medicines produced by Mylan Laboratories Limited in India.
The watchdog said on Thursday Lithuania is following the procedures, launched by the European Union, that this active ingredient meant for reducing blood pressure can no longer be used in the EU.
The Lithuanian service shared information from the European Medicines Agency, stating that some batches of medications containing valsartan had a too-large amount of N-Nitrosodiethylamine (NDEA) – a carcinogen capable of causing cancer.
All batches of valsartan produced by the above-mentioned company have already been recalled in Switzerland, Croatia, Italy and Spain. Other countries plan to announce recalls shortly. There are no medicines with valsartan produced by that company in the Czech repiublic, Iceland, Sweden, Cyprus and Finland.
In July, the European Medicines Agency recalled blood pressure reducing medications containing valsartam, an active ingredient produced by China's Zhejiang Huahai Pharmaceuticals, as they were also found to contain NDEA impurities.
Lithuania's State Medicines Control Agency says there's no direct threat to people's health and a bigger risk would be to suddenly discontinue using medicines prescribed fro high blood pressure. The European Medicines Agency is currently carrying out additional tests over medicine impurities.