Drug products from the originator and a couple of generic products utilizing valsartan from other production facilities were not recalled. Subsequently, 16 marketing authorization holders recalled affected batches of more than 30 generic drugs containing impurities. These impurities were most likely related to a change in the manufacturing process of the valsartan substance implemented in 2012. The drugs were recalled due to high concentrations of probable carcinogenic nitrosamines found in selected lots of ARB substances and generic drugs, primarily valsartan from Zhejiang Huahai Pharmaceutical Co., Ltd., Linhai, China. In accordance with the European Medicines Agency, the German Federal Institute for Drugs and Medical Devices announced recalls of generic valsartan products on July 4th, 2018. In Germany, ~8 million patients take ARBs and 2.25 million of them valsartan. In contrast to previous safety warnings/recalls, our data do not suggest an under-prescription of antihypertensives during this period.Īngiotensin receptor blockers (ARBs) are the most commonly used drugs for the treatment of arterial hypertension, heart failure, and chronic kidney disease. The majority of recalled generic valsartan products were replaced by other ARBs, predominantly candesartan, despite documented drug shortages. There were no changes in the utilization of ACEi, BB, or CCB. Simultaneously, the use of alternative ARBs increased from 77.7 DID in the second quarter of 2018 to 121.9 DID (+57%) in the fourth quarter of 2019, mainly due to an increase of candesartan dispensing to 99.8 DID (+73%). Valsartan use decreased substantially after the recalls in July 2018 from 39.0 to 14.2 DID (−64%) in the second quarter of 2019 and to 16.9 DID (−57%) in the fourth quarter of 2019. Utilization was calculated by defined daily doses per 1000 SHI-insured persons per day (DID).

ACE inhibitors (ACEi), beta-blockers (BB), and calcium channel blockers (CCB). We analyzed 290.8 million prescriptions, including all oral mono- and fixed-dose combinations of ARBs and plausible alternatives, i.e. We used our database of anonymized dispensing data from >80% of community pharmacies at the expense of the statutory health insurance (SHI) funds from January 2017 to December 2019. We analyzed the utilization of valsartan, all ARBs, and other alternative antihypertensive drugs in Germany. The impact of such a huge recall has never been explored in Europe. In 2018, contamination of generic ARBs with probable carcinogenic nitrosamines resulted in more than 30 recalls. In Germany, ~8 million patients take angiotensin receptor blockers (ARBs) and 2.25 million of them valsartan.

Whatsapp news for losartan recall 2018