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

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.

Do drug‐related safety warnings have the expected impact on drug therapy? A systematic review

“…All of the 70 publications included are observational studies based on routinely collected health data, which included health insurance or hospital records. Thus, no RCTs were found for the defined search period.…”

“…In 66 out of 72 studies, intended changes in drug therapy were investigated with different results regarding their effectiveness. Contents of the safety warnings were described as effective in 28 out of 72 studies . In 12 studies, the authors concluded that the content of the safety warnings investigated did not lead to a change in drug therapy .…”

“…In contrast, just 45% (17/38) of the studies in the “others” group were presented as ineffective or partially effective. But 53% (20/38) described an effective impact, and only 2% examined an unintended effect. Details of this group are shown in Data S2.…”

The Effects of Asthma and Bullying on Suicidal Behaviors Among US Adolescents

“…Third, the 2013 YRBS did not include information on prescribed asthma medication, current asthma status, or asthma severity. Research investigating the impact of medications with leukotriene modifiers such as inhalers and steroids has been of interest since the Food and Drug Administration mandated medication labels to contain information on possible suicidality in 2009 . Other researchers have observed that parents of children with harsh asthma conditions were more troubled about their children being victims of bullying .…”

“…Research investigating the impact of medications with leukotriene modifiers such as inhalers and steroids has been of interest since the Food and Drug Administration mandated medication labels to contain information on possible suicidality in 2009. [36][37][38][39] Other researchers have observed that parents of children with harsh asthma conditions were more troubled about their children being victims of bullying. 20 Thus, the ability to include more information on the medication prescribed to control asthma symptoms, asthma symptoms at the time of the survey, and severity of asthma could provide a better understanding of the relationship among having asthma, being bullied, and exhibiting suicidal ideation and/or behaviors.…”