{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,12]],"date-time":"2026-07-12T06:18:02Z","timestamp":1783837082421,"version":"3.55.0"},"reference-count":43,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,3,21]],"date-time":"2024-03-21T00:00:00Z","timestamp":1710979200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000133","name":"Agency for Healthcare Research and Quality","doi-asserted-by":"publisher","award":["R01HS027985"],"award-info":[{"award-number":["R01HS027985"]}],"id":[{"id":"10.13039\/100000133","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Valsartan is commonly used for cardiac conditions. In 2018, the Food and Drug Administration recalled generic valsartan due to the detection of impurities. Our objective was to determine if heart failure patients receiving valsartan at the recall date had a greater likelihood of unfavorable outcomes than patients using comparable antihypertensives.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted a cohort study of Optum's de\u2010identified Clinformatics\u00ae Datamart (July 2017\u2013January 2019). Heart failure patients with commercial or Medicare Advantage insurance who received valsartan were compared to persons who received non\u2010recalled angiotensin receptor blockers (ARBs) and angiotensin converting enzyme\u2010inhibitors (ACE\u2010Is) for 1\u2009year prior and including the recall date. Outcomes included a composite for all\u2010cause hospitalization, emergency department (ED), and urgent care (UC) use and a measure of cardiac events which included hospitalizations for acute myocardial infarction and hospitalizations\/ED\/UC visits for stroke\/transient ischemic attack, heart failure or hypertension at 6\u2010months post\u2010recall. Cox proportional hazard models with propensity score weighting compared the risk of outcomes between groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 87\u2009130 adherent patients, 15% were valsartan users and 85% were users of non\u2010recalled ARBs\/ACE\u2010Is. Valsartan use was not associated with an increased risk of all\u2010cause hospitalization\/ED\/UC use six\u2010months post\u2010recall (HR 1.00; 95% CI 0.96\u20131.03), compared with individuals taking non\u2010recalled ARBs\/ACE\u2010Is. Similarly, cardiac events 6\u2010months post\u2010recall did not differ between individuals on valsartan and non\u2010recalled ARBs\/ACE\u2010Is (HR 1.04; 95% CI 0.97\u20131.12).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The valsartan recall did not affect short\u2010term outcomes of heart failure patients. However, the recall potentially disrupted the medication regimens of patients, possibly straining the healthcare system.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5777","type":"journal-article","created":{"date-parts":[[2024,3,21]],"date-time":"2024-03-21T07:53:56Z","timestamp":1711007636000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Effects of the valsartan recall on heart failure patients: A nationwide analysis"],"prefix":"10.1002","volume":"33","author":[{"given":"Joshua W.","family":"Devine","sequence":"first","affiliation":[{"name":"Department of Public Health Des Moines University  Des Moines Iowa USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mina","family":"Tadrous","sequence":"additional","affiliation":[{"name":"Leslie Dan Faculty of Pharmacy University of Toronto  Toronto Ontario Canada"},{"name":"Women's College Research Institute  Toronto Ontario 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