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

View/ Open
Author
Lakoma, Matthew D.
Butler, Melissa G.
Larkin, Emma K.
Kharbanda, Elyse O.
Vollmer, William M.
Chen Wu, Ann
Note: Order does not necessarily reflect citation order of authors.
Published Version
https://doi.org/10.1016/j.clinthera.2015.03.027Metadata
Show full item recordCitation
Lu, Christine Y., Fang Zhang, Matthew D. Lakoma, Melissa G. Butler, Vicki Fung, Emma K. Larkin, Elyse O. Kharbanda, et al. 2015. “Asthma Treatments and Mental Health Visits After a Food and Drug Administration Label Change for Leukotriene Inhibitors.” Clinical Therapeutics 37 (6) (June): 1280–1291. doi:10.1016/j.clinthera.2015.03.027.Abstract
PurposeIn 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.
Terms of Use
This article is made available under the terms and conditions applicable to Open Access Policy Articles, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#OAPCitable link to this page
http://nrs.harvard.edu/urn-3:HUL.InstRepos:32692585
Collections
- HMS Scholarly Articles [17293]
Contact administrator regarding this item (to report mistakes or request changes)