Background: Prescription drug shortages are a significant challenge for health care systems and have profound consequences for patients unable to obtain needed medication. Several angiotensin receptor blockers (ARBs; valsartan, losartan, irbesartan) were recalled in 2018 following the detection of carcinogenic impurities.
Objectives: Examine the association between the 2018 recall of ARBs and the potential for serious adverse clinical outcomes among persons with heart failure.
Methods: A retrospective cohort analysis of persons >18 years with heart failure who were continuous users of ARBs 1 year prior to the 2018 recall. Data comprised of Medicare and commercially insured patients in the U.S. obtained using Optum’s de-identified Clinformatics Data Mart Database from 2017-2019. Controls included adult continuous users of non-recalled ARBs and angiotensin converting enzyme-inhibitors (ACE-Is). Propensity score weighted logistic regression models compared changes in a composite outcome measure of emergency/urgent care visits, hospitalizations, and mortality during the six-month period following the drug recalls. A secondary outcome of heart failure exacerbation was also evaluated.
Results: 53,981 cases received a recalled ARB and 73,632 controls received a non-recalled ARB or an ACE-Inhibitor and were included in the cohort. Increasing age and racial and ethnic individuals had increased odds of receiving a recalled ARB. Male sex (aOR=0.66; 95% CI: 0.65-0.67) and a history of myocardial infarction (aOR=0.89; 95% CI: 0.87-0.91) were less likely in the case group. After propensity score weighting, no statistically significant difference in the composite measure of all cause emergency/urgent care use, hospitalization or mortality was observed among cases and controls (aOR=0.98; 95% CI:0.96-1.00). The secondary endpoint of heart failure exacerbation was also not significant (aOR=0.98; 95% CI:0.93-1.04).
Conclusions: The national recall of certain ARBs was not associated with poor patient outcomes in this population of Medicare and commercially insured patients with heart failure. Additional research should explore how reductions in drug supply may directly impact patient outcomes across other clinical settings. Facilitating medication changes during drug recalls and subsequent shortages is critical to preventing poor patient outcomes.
