Top Pharma companies not following current good manufacturing processes: Angiotensin II receptor blockers with carcinogenic impurities: A threat to global public health

Aslam Pathan, NeuroPharmac Journal
2019 NeuroPharmac journal  
Angiotensin II receptor blockers (ARBs) are the first-line treatment in the management of hypertension used worldwide. Examples of ARBs include the drugs valsartan, losartan, irbesartan, candesartan, eprosartan, olmesartan, and telmisartan. Beginning in June 2018, FDA learned that some generic versions of the prescription drug valsartan contained unexpected impurities that posed a safety concern. The impurities in ARB medications, N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)
more » ... e probable human carcinogens (cancercausing), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) is a potential human carcinogen. Most medicines found to contain these impurities above the interim acceptable intake limits have been recalled and are no longer available in the U.S. market. FDA recalled ARBs with carcinogenic impurity, the big question is that, what about the consumers who ate carcinogenic impured medicines by paying to pharma companies? FDA should take necessary action to prevent a threat to global public health.
doi:10.37881/1.432 fatcat:gbyprfulmzdetgnsneivvpgvtq