Background: 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. Methods: We conducted a cohort study of
Optum’s de-identified Clinformatics® Datamart (July 2017-January 2019).
Heart failure patients with commercial or Medicare Advantage insurance
who received valsartan were compared to persons who received
non-recalled angiotensin receptor blockers (ARBs) and angiotensin
converting enzyme-inhibitors (ACE-Is) for 1 year prior and including the
recall date. Outcomes included a composite for all-cause
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-months post-recall. Cox proportional hazard models with propensity
score weighting compared the risk of outcomes between groups.
Results: Of the 87,130 patients, 15% were valsartan users and
85% were users of non-recalled ARBs/ACE-Is. Valsartan use was not
associated with an increased risk of all-cause hospitalization/ED/UC use
six-months post-recall (HR 1.00; 95%CI 0.96–1.03), compared with
individuals taking non-recalled ARBs/ACE-Is. Similarly, cardiac events
6-months post-recall did not differ between individuals on valsartan and
non-recalled ARBs/ACE-Is (HR 1.04; 95%CI 0.97–1.12).
Conclusions: The valsartan recall did not affect short-term
outcomes of heart failure patients. However, the recall potentially
disrupted the medication regimens of patients, possibly straining the