Key result
The 2018 ARB recalls were associated with increased medication switches (2.08 percentage points/quarter; 95% CI 2.01-2.15) and 1.40 additional MACE-related visits per 1,000 patients per quarter.
Why the study?
The long-term consequences of the 2018 ARB shortages following recalls for carcinogenic impurities and whether certain groups experienced more adverse outcomes were unknown.
Did the 2018 ARB recalls affect medication adherence, blood pressure control, and cardiovascular outcomes compared to nonrecalled antihypertensive drugs?
Population
86,507 recalled ARB users and 123,583 comparison drug users
Comparison
Recalled valsartan, losartan, and irbesartan users vs users of nonrecalled drugs (ACE-Is, nonrecalled ARBs)
Design
Difference-in-differences analysis using integrated claims and electronic health record data
Follow-up
18 months after recalls
Authors
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ARB recalls may disrupt adherence and outcomes; leaves open differential risks by subgroup and need for targeted interventions.
Observational (n=210,090)
Did the 2018 ARB recalls affect medication adherence, blood pressure control, and cardiovascular outcomes compared to nonrecalled antihypertensive drugs?
The 2018 ARB recalls led to immediate medication switching but had minimal overall impact on clinical outcomes, though small increases in medication gaps and MACE-related visits emerged after 1 year.
Kim et al. (2025) conducted an observational in Hypertension (n=210,090). Recalled ARBs (valsartan, losartan, irbesartan) vs. Similar, nonrecalled drugs (ACE-Is, nonrecalled ARBs) was evaluated on Proportion of days covered (PDC) for ARBs and similar drugs, uncontrolled blood pressure, major cardiovascular event (MACE)-related acute care visits, and all-cause ambulatory care visits. The 2018 ARB recalls were associated with increased medication switches (2.08 percentage points/quarter; 95% CI 2.01-2.15) and 1.40 additional MACE-related visits per 1,000 patients per quarter.
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