Key result
Valsartan use at the time of the 2018 recall was associated with a higher risk of all-cause acute care use and composite cardiac events.
Why the study?
The influence of the July 2018 FDA valsartan recall and subsequent drug shortage on clinical outcomes in hypertensive patients was unknown.
Does the 2018 valsartan recall increase adverse clinical events in hypertensive patients compared to nonrecalled ARBs/ACEis?
Cohort (n=586,406)
Does the 2018 valsartan recall increase adverse clinical events in hypertensive patients compared to nonrecalled ARBs/ACEis?
The 2018 valsartan recall was associated with an increased risk of adverse cardiac events and healthcare utilization, highlighting the clinical impact of drug shortages.
Answers are grounded in this paper and cite their sources.
May signal care disruptions during antihypertensive shortages; leaves open whether recall directly affected outcomes or reflects confounding.
BACKGROUND: 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-matched group using nonrecalled angiotensin receptor blockers and angiotensin-converting enzyme inhibitors. METHODS AND RESULTS: We used Optum's deidentified Clinformatics Datamart (July 2017-January 2019). Hypertensive patients who received valsartan or nonrecalled angiotensin receptor blockers/angiotensin-converting 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-cause hospitalization, all-cause emergency department visit, and all-cause 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, 76 934 received valsartan, and 509 472 received a nonrecalled angiotensin receptor blocker/angiotensin-converting enzyme inhibitor. Valsartan use at the time of recall was associated with a higher risk of all-cause hospitalization, emergency department use, or urgent care use (hazard ratio [HR], 1.02 [95% CI, 1.00-1.04]) and the composite of cardiac events (HR, 1.22 [95% CI, 1.15-1.29]) within 6 months after the recall. CONCLUSIONS: The valsartan recall and shortage affected hypertensive patients. Local- and national-level systems need to be enhanced to protect patients from drug shortages by providing safe and reliable medication alternatives.
No takes yet. Share an insight, caveat, or question.
Devine et al. (2023) conducted a cohort in Hypertension (n=586,406). Valsartan vs. Nonrecalled angiotensin receptor blockers and angiotensin-converting enzyme inhibitors was evaluated on Composite measure of all-cause hospitalization, all-cause emergency department visit, and all-cause urgent care visit (HR 1.02, 95% CI 1.00-1.04). Valsartan use at the time of the 2018 recall was associated with a higher risk of all-cause acute care use and composite cardiac events.
Synapse has enriched 10 related papers. Consider them for comparative context: