{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T16:13:14Z","timestamp":1779293594943,"version":"3.51.4"},"reference-count":39,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2024,1,2]]},"abstract":"<jats:sec sec-type=\"background\" xml:lang=\"en\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p xml:lang=\"en\">Valsartan was recalled by the US Food and Drug Administration in July 2018 for carcinogenic impurities, resulting in a drug shortage and management challenges for valsartan users. The influence of the valsartan recall on clinical outcomes is unknown. We compared the risk of adverse events between hypertensive patients using valsartan and a propensity score\u2013matched group using nonrecalled angiotensin receptor blockers and angiotensin\u2010converting enzyme inhibitors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Methods and Results<\/jats:title>\n                    <jats:p xml:lang=\"en\">We used Optum's deidentified Clinformatics Datamart (July 2017\u2013January 2019). Hypertensive patients who received valsartan or nonrecalled angiotensin receptor blockers\/angiotensin\u2010converting enzyme inhibitors for 1 year before and on the recall date were compared. Primary outcomes were measured in the 6 months following the recall and included: (1) a composite measure of all\u2010cause hospitalization, all\u2010cause emergency department visit, and all\u2010cause urgent care visit, and (2) a composite cardiac event measure of hospitalizations for acute myocardial infarction and hospitalizations\/emergency department visits\/urgent care visits for stroke\/transient ischemic attack, heart failure, or hypertension. We compared the risk of outcomes between treatment groups using Cox proportional hazard models. Of the hypertensive patients, 76\u2009934 received valsartan, and 509\u2009472 received a nonrecalled angiotensin receptor blocker\/angiotensin\u2010converting enzyme inhibitor. Valsartan use at the time of recall was associated with a higher risk of all\u2010cause hospitalization, emergency department use, or urgent care use (hazard ratio [HR], 1.02 [95% CI, 1.00\u20131.04]) and the composite of cardiac events (HR, 1.22 [95% CI, 1.15\u20131.29]) within 6 months after the recall.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p xml:lang=\"en\">The valsartan recall and shortage affected hypertensive patients. Local\u2010 and national\u2010level systems need to be enhanced to protect patients from drug shortages by providing safe and reliable medication alternatives.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/jaha.123.032266","type":"journal-article","created":{"date-parts":[[2023,12,29]],"date-time":"2023-12-29T05:41:50Z","timestamp":1703828510000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["A Retrospective Cohort Study of the 2018 Angiotensin Receptor Blocker Recalls and Subsequent Drug Shortages in Patients With Hypertension"],"prefix":"10.1161","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-1508-3846","authenticated-orcid":false,"given":"Joshua W.","family":"Devine","sequence":"first","affiliation":[{"name":"Des Moines University Department of Public Health Des Moines IA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1911-6129","authenticated-orcid":false,"given":"Mina","family":"Tadrous","sequence":"additional","affiliation":[{"name":"Leslie Dan Faculty of Pharmacy University of Toronto Ontario Canada"},{"name":"Institute for Health System Solutions and Virtual Care Women\u2019s College Hospital Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0118-4986","authenticated-orcid":false,"given":"Inmaculada","family":"Hernandez","sequence":"additional","affiliation":[{"name":"University of California San Diego School of Pharmacy and Pharmaceutical Sciences La Jolla CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2924-6165","authenticated-orcid":false,"given":"Katherine","family":"Callaway Kim","sequence":"additional","affiliation":[{"name":"Division of General Internal Medicine, Department of Medicine University of Pittsburgh School of Medicine Pittsburgh PA USA"},{"name":"Department of Health Policy and Management University of Pittsburgh School of Public Health Pittsburgh PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott D.","family":"Rothenberger","sequence":"additional","affiliation":[{"name":"Division of General Internal Medicine, Department of Medicine University of Pittsburgh School of Medicine Pittsburgh PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7117-9536","authenticated-orcid":false,"given":"Nandita","family":"Mukhopadhyay","sequence":"additional","affiliation":[{"name":"University of Pittsburgh School of Dental Medicine Department of Oral and Craniofacial Sciences, Center for Craniofacial and Dental Genetics Pittsburgh PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Walid F.","family":"Gellad","sequence":"additional","affiliation":[{"name":"Division of General Internal Medicine, Department of Medicine University of Pittsburgh School of Medicine Pittsburgh PA USA"},{"name":"Center for Health Equity Research and Promotion VA Pittsburgh Healthcare System Pittsburgh PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8977-1850","authenticated-orcid":false,"given":"Katie J.","family":"Suda","sequence":"additional","affiliation":[{"name":"Division of General Internal Medicine, Department of Medicine University of Pittsburgh School of Medicine Pittsburgh PA USA"},{"name":"Center for Health Equity Research and Promotion VA Pittsburgh Healthcare System Pittsburgh PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1161\/HYP.0000000000000066"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1161\/HYPERTENSIONAHA.120.15026"},{"key":"e_1_3_2_4_2","unstructured":"FDA updates and press announcements on angiotensin II receptor blocker (ARB) recalls (valsartan losartan and irbesartan). 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