Varenicline and Nicotine Replacement Use Associated With US Food and Drug Administration Drug Safety Communications

R. Desai,M. Good,A. San-Juan-Rodriguez,Andrew Henriksen,F. Cunningham,I. Hernandez,C. Good

Published 2019 in JAMA Network Open

ABSTRACT

Key Points Question Did use of varenicline change after early US Food and Drug Administration drug safety communications regarding neuropsychiatric adverse events? Findings This cross-sectional study observed a reduction in varenicline prescribing following the release of US Food and Drug Administration drug safety communications on the medication. Interrupted time series analysis showed a 68.7% decrease in Veterans Health Administration outpatient prescriptions and a 38.0% decrease in Medicaid prescriptions. Meaning In the wake of US Food and Drug Administration and Veterans Health Administration communications, prescriptions for varenicline decreased significantly, which may have been associated with negative public health consequences.

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