ABSTRACT
OBJECTIVE: In March 2020, the US Food and Drug Administration (FDA) required a black box warning for montelukast due to serious mental health side effects. We hypothesized the warning would lead to an overall decrease in reports of mental health symptoms and disorders related to montelukast in both -pre-adolescent and adolescent groups. METHODS: Adverse events of pre-adolescent and adolescent children taking montelukast sodium were reviewed from March 1, 2018 to March 3, 2020 and March 4, 2020 to February 28, 2022 using the FDA's Adverse Events Reporting System. The objective was to determine if mental health adverse event reports were influenced by placement of a Boxed Warning. Adverse reactions were grouped into 8 categories deemed to be related to mental health guided by the research team's interpretation of the FDA Sentinel Report. Chi-square tests were used to compare time periods and reports of the mental health categories. RESULTS: Of the 1570 reports assessed, 1295 (82.5%) included ≥1 mental health concern. Nine hundred ninety-six (84.2%) of the 1183 reports involving pre-adolescents and 299 (77.3%) of the 387 reports involving adolescents included ≥1 mental health reaction. Statistically significant changes for pre-adolescents were found in reports related to depression (χ2 (1) = 4.30, p = 0.044), and sleep (χ2 (1) = 5.74, p = 0.019), which both decreased between the pre and post periods. The only statistically significant change across categories for adolescents was a reduction in aggression reports between time periods (χ2 (1) = 8.5, p = 0.004). CONCLUSIONS: After placement of an FDA black box warning on montelukast, total number of reports -including mental health adverse events decreased in pre-adolescents; however, several categories -assessed increased for adolescents.
ABSTRACT
Palestinians in the West Bank are at heightened risk for mental health problems. Limited availability of clinicians and a host of geopolitical, topographical, and infrastructural challenges create significant regional barriers to clinic-based care. The objective of this study was to examine whether mHealth approaches that leverage mobile phones for remote mental health treatment may be viable alternatives. We surveyed 272 Palestinian adults in urban, rural, and refugee camp settings. Most participants (93.4%) reported owning mobile phones. The penetration of mobile devices was high across all study sites. Males and females did not differ in their access to this resource. Among mobile phone owners, 79.9% had smartphones, 32.2% had basic mobile phones, and 12.2% owned both. Respondents reported having reliable access to electricity (99.6%) and Wi-Fi (80.9%). Almost all mobile phone owners (99.6%) reported using social media such as Facebook, WhatsApp, or Twitter. When asked to estimate the prevalence of mental health problems in the region, 61.4% of participants reported that over half of the people in their communities struggled with depression, posttraumatic stress, or auditory hallucinations. Most participants indicated that they would personally be interested in mHealth for Mental Health options such as bi-directional texting with clinicians (68.8%), smartphone applications (66.5%), unidirectional support texts (64.7%), or web-based interventions (64.0%). Given the Palestinian populations' broad access to technology and technological infrastructure, need for care, and openness to engage in mobile interventions, mHealth should be considered a promising strategy for mental health services in the West Bank.
