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Clin Ther. 2015 Jun 1;37(6):1280-91. doi: 10.1016/j.clinthera.2015.03.027. Epub 2015 Apr 25.

Asthma Treatments and Mental Health Visits After a Food and Drug Administration Label Change for Leukotriene Inhibitors.

Author information

1
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts. Electronic address: christine_lu@harvardpilgrim.org.
2
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
3
Population Health, The Argus Group, Hamilton, Bermuda.
4
Mongan Institute for Health Policy, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
5
Vanderbilt University School of Medicine, Nashville, Tennessee.
6
HealthPartners Institute for Education and Research, Minneapolis, Minnesota.
7
Center for Health Research Northwest, Kaiser Permanente Northwest, Portland, Oregon.
8
Division of Research, Kaiser Permanente Northern California, Oakland, California.
9
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts; Division of General Pediatrics, Department of Pediatrics, Children's Hospital, Boston, Massachusetts.

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.

KEYWORDS:

FDA; asthma; drug tolerability; leukotriene inhibitors; montelukast; risk communication

PMID:
25920571
PMCID:
PMC5101625
DOI:
10.1016/j.clinthera.2015.03.027
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. M.G. Butler reports contracts with the FDA and Novartis outside the submitted work. V. Fung reports financial interest in Merck. The authors have indicated that they have no other conflicts of interest regarding the content of this article.

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