PDF(Pubmed)
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.
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.
摘要：
目标：2020年3月，由于严重的精神健康副作用，美国食品和药物管理局（FDA）要求孟鲁司特黑匣子警告。我们假设该警告将导致青春期前和青春期人群中与孟鲁司特相关的精神健康症状和疾病的报告总体减少。
方法：2018年3月1日至2020年3月3日和2020年3月4日至2022年2月28日，使用FDA的不良事件报告系统审查了服用孟鲁司特钠的青春期前和青春期儿童的不良事件。目的是确定精神健康不良事件报告是否受到黑框警告的影响。根据研究小组对FDA哨兵报告的解释，将不良反应分为8类，认为与心理健康有关。卡方检验用于比较时间段和心理健康类别的报告。
结果：在评估的1570份报告中，1295（82.5%）包括≥1个心理健康问题。涉及青少年前期的1183份报告中有96份（84.2％），涉及青少年的387份报告中有299份（77.3％）包括≥1种心理健康反应。在与抑郁症相关的报告中发现了青春期前的统计学显着变化（χ2（1）=4.30，p=0.044），和睡眠（χ2（1）=5.74，p=0.019），在前期和后期之间都有所下降。青少年类别之间唯一具有统计学意义的变化是不同时间段之间的侵略报告减少（χ2（1）=8.5，p=0.004）。
结论：在孟鲁司特上放置FDA黑匣子警告后，报告总数-包括青少年前的精神健康不良事件减少；然而，几个类别-青少年评估增加。
方法：2018年3月1日至2020年3月3日和2020年3月4日至2022年2月28日，使用FDA的不良事件报告系统审查了服用孟鲁司特钠的青春期前和青春期儿童的不良事件。目的是确定精神健康不良事件报告是否受到黑框警告的影响。根据研究小组对FDA哨兵报告的解释，将不良反应分为8类，认为与心理健康有关。卡方检验用于比较时间段和心理健康类别的报告。
结果：在评估的1570份报告中，1295（82.5%）包括≥1个心理健康问题。涉及青少年前期的1183份报告中有96份（84.2％），涉及青少年的387份报告中有299份（77.3％）包括≥1种心理健康反应。在与抑郁症相关的报告中发现了青春期前的统计学显着变化（χ2（1）=4.30，p=0.044），和睡眠（χ2（1）=5.74，p=0.019），在前期和后期之间都有所下降。青少年类别之间唯一具有统计学意义的变化是不同时间段之间的侵略报告减少（χ2（1）=8.5，p=0.004）。
结论：在孟鲁司特上放置FDA黑匣子警告后，报告总数-包括青少年前的精神健康不良事件减少；然而，几个类别-青少年评估增加。
