Impact of national valsartan recalls on Veterans’ outcomes

Abstract

Background and Aims: Chemical impurities discovered in angiotensin receptor blocker (ARB) products in late 2018–2019 resulted in recalls of various products and has likely had downstream effects for patients and prescribers. The purpose of this study is to determine how the valsartan recall impacted clinical endpoints and prescribing of antihypertensives. Methods: This was a retrospective, single-center, cohort study including patients receiving recalled valsartan with essential hypertension who were mailed a recall letter on 12 March 2019. Mean blood pressure endpoints were collected 6 months before (pre-recall) and after the recall letter was mailed (post-recall). Antihypertensive medication changes and titrations were also characterized post-recall. Results: A total of 300 patients meeting eligibility criteria were included. There was no statistically significant difference in mean systolic blood pressure (SBP) or diastolic blood pressure (DBP) when pre- and post-recall blood pressures were compared (SBP: 137.2 mmHg versus 135.8 mmHg, p = 0.125; DBP: 78.6 mmHg versus 78.5 mmHg, p = 0.900). In addition, the percentage of patients with controlled blood pressure readings was similar in the pre- and post-recall timeframes (28% versus 27%, p = 0.72). A total of 33 medication changes involving valsartan occurred, with approximately one-third being changed to another ARB ( n = 11) or drug class ( n = 12). In total, 11 valsartan medication changes were specifically documented to be related to the valsartan recall. Conclusion: The results of this study indicate the valsartan recalls that occurred in 2019 did not significantly impact the clinical outcomes of the studied population. Plain Language Summary Impact of a medication recall on Veterans’ outcomes Background: Chemical impurities discovered in a class of blood pressure medications known as angiotensin receptor blockers (ARBs) occurred in late 2018–2019. This resulted in recalls of various products and has likely had downstream effects for patients and prescribers. Objective: The purpose of this study is to determine how the recall of valsartan, which is a medication in the ARB class, impacted clinical endpoints and prescribing of medications for blood pressure. Methods: This was a retrospective, single-center, cohort study including patients receiving recalled valsartan with high blood pressure who were mailed a recall letter on 12 March 2019. Blood pressure endpoints were collected 6 months before (pre-recall) and after the recall letter was mailed (post-recall). Medication changes and titrations were also characterized post-recall. Results: Three hundred patients meeting eligibility criteria were included. There was no difference found in systolic blood pressure (SBP) or diastolic blood pressure (DBP) when pre- and post-recall blood pressures were compared (SBP: 137.2 mmHg versus 135.8 mmHg; DBP: 78.6 mmHg versus 78.5 mmHg). In addition, the percent of patients with controlled blood pressure readings was similar in the pre- and post-recall timeframes (28% versus 27%). A total of 33 medication changes involving valsartan occurred, with approximately one-third being changed to another ARB ( n = 11) or drug class ( n = 12). Eleven valsartan medication changes were specifically documented to be related to the valsartan recall. Conclusions: The results of this study indicate the valsartan recalls that occurred in 2019 did not significantly impact the clinical outcomes of the studied population.

Effects of the valsartan recall on heart failure patients: A nationwide analysis

“…Our findings demonstrating little harm of the valsartan recall in heart failure patients, are similar to those of other investigators using cohorts from Ontario, Canada and a single U.S. Veterans Affairs (VA) facility 19,40 . While there were small increases in ED visits for hypertension and for stroke/TIA post‐recall in the Ontario cohort, there were no differences in myocardial infarction or heart failure 19 .…”

“…Our findings demonstrating little harm of the valsartan recall in heart failure patients, are similar to those of other investigators using cohorts from Ontario, Canada and a single U.S. Veterans Affairs (VA) facility. 19,40 While there were small increases in ED visits for hypertension and for stroke/TIA post-recall in the Ontario cohort, there were no differences in myocardial infarction or heart failure. 19 We did observe some signals of increased risk for health care utilization, specifically, all-cause urgent care use and hospitalizations related T A B L E 1 Patient characteristics for persons receiving valsartan when the FDA recall announcement occurred (exposed group) or individuals on ARBs or ACE-Is that were not included in the FDA recall (unexposed group), before and after propensity-score weighting.…”

A Retrospective Cohort Study of the 2018 Angiotensin Receptor Blocker (ARB) Recalls and Subsequent Drug Shortages on Patients with Hypertension

“…Two percent of Veterans receiving recalled valsartan had an ED visit with a hypertensive emergency within 3 months post-recall. 32 Another Canadian study using an ecological design reported small increases in hypertension-related ED visits at the population-level in adults >65 years of age with temporal increases in all-cause ED visits and hospitalizations. 22 However, attributing these events to the recall is difficult because neither study included a comparison group.…”

“…14 However, a study of a single Veterans Affairs (VA) facility found that only 4% of Veterans on valsartan switched their medication to an alternative antihypertensive post-2018-recall. 32 Unlike the national analysis across multiple-health care systems, the integrated VA health care system had the ability to identify and educate affected patients. A mailing included instructions for Veterans to continue taking their current valsartan supply, assurances that subsequent prescriptions would be filled with non-recalled valsartan, and education on the risk of uncontrolled blood pressure and potential for carcinogen exposure.…”

“…A mailing included instructions for Veterans to continue taking their current valsartan supply, assurances that subsequent prescriptions would be filled with non-recalled valsartan, and education on the risk of uncontrolled blood pressure and potential for carcinogen exposure. 32 The extent to which other health-systems or pharmacies were able to provide outreach to affected patients is unknown.…”