{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T15:45:16Z","timestamp":1787067916666,"version":"build-2736575974"},"reference-count":14,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2023,4,17]],"date-time":"2023-04-17T00:00:00Z","timestamp":1681689600000},"content-version":"unspecified","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000038","name":"US Food and Drug Administration","doi-asserted-by":"crossref","award":["75F40119F19002"],"award-info":[{"award-number":["75F40119F19002"]}],"id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000024","name":"Canadian Institutes of Health Research","doi-asserted-by":"publisher","award":["DSE-146021"],"award-info":[{"award-number":["DSE-146021"]}],"id":[{"id":"10.13039\/501100000024","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,3,31]]},"published-print":{"date-parts":[[2023,4]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To examine valsartan, losartan and irbesartan usage and switching patterns in the USA, UK, Canada and Denmark before and after July 2018, when the first Angiotensin-Receptor-Blocker (ARB) (valsartan) was recalled.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Retrospective cohort study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>USA, Canadian administrative healthcare data, Danish National Prescription Registry and UK primary care electronic health records.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Patients aged 18 years and older between January 2014 and December 2020.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>Valsartan, losartan and irbesartan.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome<\/jats:title>\n                    <jats:p>Monthly percentages of individual ARB episodes, new users and switches to another ARB, ACE inhibitors (ACEI) or calcium channel blockers containing products.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We identified 10.8, 3.2, 1.8 and 1.2 million ARB users in the USA, UK, Canada and Denmark, respectively. Overall proportions of valsartan, losartan and irbesartan use were 18.4%, 67.9% and 5.2% in the USA; 3.1%, 48.3% and 10.2% in the UK, 16.3%, 11.4% and 18.3% in Canada, 1%, 93.5% and 0.6% in Denmark. In July 2018, we observed an immediate steep decline in the proportion of valsartan use in the USA and Canada. A similar trend was observed in Denmark; however, the decline was only minimal. We observed no change in trends of ARB use in the UK. Accompanying the valsartan decline was an increase in switching to other ARBs in the USA, Canada and Denmark. There was a small increase in switching to ACEI relative to the valsartan-to-other-ARBs switch. We also observed increased switching from other affected ARBs, losartan and irbesartan, to other ARBs throughout 2019, in the USA and Canada, although the usage trends in the USA remained unchanged.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The first recall notice for valsartan resulted in substantial decline in usage due to increased switching to other ARBs. Subsequent notices for losartan and irbesartan were also associated with increased switching around the time of the recall, however, overall usage trends remained unchanged.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-070985","type":"journal-article","created":{"date-parts":[[2023,4,17]],"date-time":"2023-04-17T10:46:35Z","timestamp":1681728395000},"page":"e070985","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":22,"title":["Valsartan, Losartan and Irbesartan use in the USA, UK, Canada and Denmark after the nitrosamine recalls: a descriptive cohort study"],"prefix":"10.1136","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8971-9748","authenticated-orcid":false,"given":"Efe","family":"Eworuke","sequence":"first","affiliation":[{"name":"Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mayura","family":"Shinde","sequence":"additional","affiliation":[{"name":"Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Hou","sequence":"additional","affiliation":[{"name":"Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J","family":"Paterson","sequence":"additional","affiliation":[{"name":"Canadian Network for Observational Drug Effect Studies (CNODES), Montr\u00e9al, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter Bj\u00f8dstrup","family":"Jensen","sequence":"additional","affiliation":[{"name":"University of Southern Denmark, Odense, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith C","family":"Maro","sequence":"additional","affiliation":[{"name":"Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashish","family":"Rai","sequence":"additional","affiliation":[{"name":"Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9486-4974","authenticated-orcid":false,"given":"Daniel","family":"Scarnecchia","sequence":"additional","affiliation":[{"name":"Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dinci","family":"Pennap","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Woronow","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca E","family":"Ghosh","sequence":"additional","affiliation":[{"name":"Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5620-0536","authenticated-orcid":false,"given":"Stephen","family":"Welburn","sequence":"additional","affiliation":[{"name":"Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anton","family":"Pottegard","sequence":"additional","affiliation":[{"name":"Hospital Pharmacy, Odense Universitetshospital, Odense, Denmark"},{"name":"Department of Public Health, Clinical Pharmacology and Pharmacy, University of Southern Denmark, Odense, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert W","family":"Platt","sequence":"additional","affiliation":[{"name":"Canadian Network for Observational Drug Effect Studies (CNODES), Montr\u00e9al, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hana","family":"Lee","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6266-4414","authenticated-orcid":false,"given":"Marie C","family":"Bradley","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,4,17]]},"reference":[{"key":"2025101814293220000_13.4.e070985.1","unstructured":"FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. 2018. 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Available: https:\/\/recalls-rappels.canada.ca\/en\/alert-recall\/several-drugs-containing-valsartan-being-recalled-due-contamination-potential [Accessed 26 May 2022]."},{"key":"2025101814293220000_13.4.e070985.4","unstructured":"Blood pressure and heart medication recalled from pharmacie. 2018. Available: https:\/\/www.gov.uk\/government\/news\/blood-pressure-and-heart-medication-recalled-from-pharmacies [Accessed 26 May 2022]."},{"key":"2025101814293220000_13.4.e070985.5","unstructured":"International Agency for Research on Cancer . IARC monographs on the evaluation of carcinogenic risks to humans. overall evaluations of carcinogenicity: an updating of IARC monographs. 1987;1\u201342."},{"key":"2025101814293220000_13.4.e070985.6","unstructured":"US Food and Drug Administration . Information about nitrosamine impurities in medications. 2022. 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