Since 2018, NDMA and other nitrosamines have been observed in a range of different pharmaceuticals. On the 5th July 2018, the European Medical Agency gave notice on their website that selected batches of valsartan were to be recalled with immediate effect. In performing the routine analysis, the quality control (QC) chemists found that there were approaching 60 ppm of N-nitrosodimethylamine (NDMA), which is high enough to cause one extra case of cancer in 500 patients. It is often given to patients directly after a heart attack.
It is a selective angiotensin II receptor blocker (ARB) which dilates blood vessels and so consequently reduces blood pressure. Zhejiang Huahai pharmaceuticals produce valsartan, which is a prescription-only drug to treat high blood pressure and heart failure. In the summer of 2018, the pharmaceutical landscape for the manufacture of small molecules changed forever with the discovery of a small genotoxic compound in a batch of pharmaceuticals manufactured in China.
0 kommentar(er)
