Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India.
European Directorate for the Quality of Medicines has now suspended the manufacturer’s CEP, effectively prohibiting the use of its valsartan in EU medicines.
In addition, national authorities in the EU have started recalling affected batches of medicines containing Mylan’s valsartan and are conducting further tests to determine the extent of the contamination.
NDEA and the related compound N-nitrosodimethylamine (NDMA), which have been seen in ‘sartans’ from other manufacturers, are classified as probable human carcinogens (substances that could cause cancer).
Companies marketing sartan medicines in the EU have been asked to test their products for these impurities. Additional testing is being carried out by EU laboratories. The European Medicines Agency will update the public as soon as new information becomes available.