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


RESULTS
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.


CONCLUSIONS
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.
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts. Electronic address: christine_lu@harvardpilgrim.org.
Christine Y
CY
Lu
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
Fang
F
Zhang
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
Matthew D
MD
Lakoma
Population Health, The Argus Group, Hamilton, Bermuda.
Melissa G
MG
Butler
Mongan Institute for Health Policy, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Vicki
V
Fung
Vanderbilt University School of Medicine, Nashville, Tennessee.
Emma K
EK
Larkin
HealthPartners Institute for Education and Research, Minneapolis, Minnesota.
Elyse O
EO
Kharbanda
Center for Health Research Northwest, Kaiser Permanente Northwest, Portland, Oregon.
William M
WM
Vollmer
Division of Research, Kaiser Permanente Northern California, Oakland, California.
Tracy
T
Lieu
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
Stephen B
SB
Soumerai
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.
Ann
A
Chen Wu
D000293:Adolescent; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D003863:Depression / Q000139:chemically induced* / Q000628:therapy; D004348:Drug Labeling; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D065186:Interrupted Time Series Analysis; D020024:Leukotriene Antagonists / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008605:Mental Health Services / Q000706:statistics & numerical data*; D013406:Suicide, Attempted / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
D020024:Leukotriene Antagonists
FDA; asthma; drug tolerability; leukotriene inhibitors; montelukast; risk communication