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1000 Titel
  • Impact of angiotensin receptor blocker product recalls on antihypertensive prescribing in Germany
1000 Autor/in
  1. Rudolph, Ulrike Maria |
  2. Enners, Salka |
  3. Kieble, Marita |
  4. Mahfoud, Felix |
  5. Böhm, Michael |
  6. Laufs, Ulrich |
  7. Schulz, Martin |
1000 Erscheinungsjahr 2020
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2020-10-14
1000 Erschienen in
1000 Quellenangabe
  • 35(10):903-911
1000 Copyrightjahr
  • 2020
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1038/s41371-020-00425-z |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8502678/ |
1000 Publikationsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • In Germany, ~8 million patients take angiotensin receptor blockers (ARBs) and 2.25 million of them valsartan. In 2018, contamination of generic ARBs with probable carcinogenic nitrosamines resulted in more than 30 recalls. The impact of such a huge recall has never been explored in Europe. We analyzed the utilization of valsartan, all ARBs, and other alternative antihypertensive drugs in Germany. 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 290.8 million prescriptions, including all oral mono- and fixed-dose combinations of ARBs and plausible alternatives, i.e. ACE inhibitors (ACEi), beta-blockers (BB), and calcium channel blockers (CCB). Utilization was calculated by defined daily doses per 1000 SHI-insured persons per day (DID). 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. 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%). There were no changes in the utilization of ACEi, BB, or CCB. The majority of recalled generic valsartan products were replaced by other ARBs, predominantly candesartan, despite documented drug shortages. In contrast to previous safety warnings/recalls, our data do not suggest an under-prescription of antihypertensives during this period.
1000 Sacherschließung
lokal Hypertension/epidemiology [MeSH]
lokal Article
lokal Hypertension/drug therapy [MeSH]
lokal Angiotensin Receptor Antagonists/adverse effects [MeSH]
lokal Antihypertensive Agents/adverse effects [MeSH]
lokal Humans [MeSH]
lokal Product Recalls and Withdrawals [MeSH]
lokal Angiotensin-Converting Enzyme Inhibitors [MeSH]
lokal Prognosis
lokal Hypertension
lokal Preventive medicine
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0002-8055-8519|https://orcid.org/0000-0001-6706-295X|https://frl.publisso.de/adhoc/uri/S2llYmxlLCBNYXJpdGE=|https://orcid.org/0000-0002-4425-549X|https://frl.publisso.de/adhoc/uri/QsO2aG0sIE1pY2hhZWw=|https://frl.publisso.de/adhoc/uri/TGF1ZnMsIFVscmljaA==|https://orcid.org/0000-0002-5876-7322
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1000 Erstellt am 2023-11-18T10:19:54.123+0100
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