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Updated: Jun 30, 2025
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Lumped-Parameter and Finite Element Modeling of Heart Failure with Preserved Ejection Fraction
Published on: February 13, 2021
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Effects of the valsartan recall on heart failure patients: A nationwide analysis
Joshua W Devine1, Mina Tadrous2,3, Inmaculada Hernandez4
1Department of Public Health, Des Moines University, Des Moines, Iowa, USA.
Pharmacoepidemiology and Drug Safety
|March 21, 2024
Summary
The 2018 valsartan recall did not increase adverse events for heart failure patients. Short-term outcomes remained stable, though medication changes may have impacted healthcare systems.
Area of Science:
- Cardiology
- Pharmacovigilance
- Health Services Research
Background:
- Valsartan, a common cardiac medication, was recalled in 2018 due to detected impurities.
- This recall raised concerns about the safety of valsartan for patients with heart failure.
Purpose of the Study:
- To evaluate the impact of the valsartan recall on heart failure patients.
- To compare unfavorable outcomes in patients using valsartan versus comparable antihypertensives post-recall.
Main Methods:
- A cohort study analyzed de-identified insurance data from July 2017 to January 2019.
- Heart failure patients on valsartan were compared to those on non-recalled angiotensin receptor blockers (ARBs) and angiotensin-converting enzyme-inhibitors (ACE-Is).
- Outcomes assessed included composite measures of hospitalization, emergency department visits, and cardiac events within six months post-recall, using Cox proportional hazard models with propensity score weighting.
Main Results:
- Valsartan use was not associated with increased risk for all-cause hospitalization, emergency department, or urgent care visits (HR 1.00; 95% CI 0.96-1.03).
- Cardiac events, including myocardial infarction, stroke, heart failure, or hypertension, also did not differ significantly between groups (HR 1.04; 95% CI 0.97-1.12).
Conclusions:
- The valsartan recall did not negatively impact short-term outcomes for heart failure patients.
- Potential disruptions to patient medication regimens and healthcare system strain warrant further consideration.
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