The European medicines Agency (Ema) draws conclusions from the scandal of contaminated blood-pressure-lowering drug. Companies that manufacture blood pressure lowering drugs on the Basis of Sartans – a certain kind of ingredients, you will need to revise their manufacturing processes, according to the Department.
After a transition period of two years medicines in the EU on the market, no quantifiable amounts of nitrosamines. First of all, the MDR had reported about it.
in mid-2018, it was revealed that certain batches of the blood pressure of the core were contaminated with potentially cancer-causing nitro amines. According to an estimate by the Federal government in 2017, approximately 900 000 patients could have ingested contaminated medium.
The additional cancer risk caused by the contaminated medications, is very low, it was said by the Ema. The authority expects to: Would take 100 000 patients over six years, the maximum allowed dose of a particularly strong with the fabric NDMA-contaminated blood-pressure-lowering drug, it could result in 22 additional cases of Cancer.