Abstract
Purpose
In 2009, the US Food and Drug Administration (FDA) mandated a label change for leukotriene
inhibitors (LTIs) to include neuropsychiatric adverse events (eg, depression and suicidality)
as a precaution. This study investigated how this label change affected the use of
LTIs and other asthma controller medications, mental health visits, and suicide attempts.
Methods
We analyzed data (2005-2010) from 5 large health plans in the US Population-Based
Effectiveness in Asthma and Lung Diseases (PEAL) Network. The study cohort included
children and adolescents (n = 30,000), young adults (n = 20,000), and adults (n =
90,000) with asthma. We used interrupted time series to examine changes in rates of
LTI dispensings, non-LTI dispensings, mental health visits, and suicide attempts (using
a validated algorithm based on a combination of diagnoses of injury or poisoning and
psychiatric conditions).
Findings
The label change was associated with abrupt reductions in LTI use among all age groups
(relative reductions of 8.3%, 15.1%, and 6.0% among adolescents, young adults, and
adults, respectively, compared with expected rates at 1 year after the warnings).
Although we detected immediate offset increases in non-LTI asthma medication use,
these increases were not sustained among adolescents and young adults. There were
small increases in mental health visits among LTI users.
Implications
The FDA label change for LTIs communicated possible risk of neuropsychiatric events.
Communication and enhanced awareness may have increased reporting of mental health
symptoms among young adults and adults. It is important to assess intended and unintended
consequences of FDA warnings and label changes.
Key words
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Article info
Publication history
Published online: April 25, 2015
Accepted:
March 9,
2015
Identification
Copyright
© 2015 Elsevier HS Journals, Inc. Published by Elsevier Inc. All rights reserved.
