From the Division of Pharmacovigilance, Office of Surveillance and Epidemiology.
Division of Psychiatry, Office of New Drugs.
J Clin Psychopharmacol. 2022;42(3):238-246. doi: 10.1097/JCP.0000000000001547.
PURPOSE/BACKGROUND: Acute hyperkinetic movement disorders have been reported with the concomitant use of attention-deficit/hyperactivity disorder (ADHD) stimulants and antipsychotics in children and adolescents. We analyzed postmarketing reports of suspected acute hyperkinetic movement disorder associated with concomitant use of ADHD stimulants and antipsychotics.
METHODS/PROCEDURES: We searched for postmarketing reports of acute hyperkinetic movement disorders associated with concomitant use of ADHD stimulants-antipsychotics in the US Food and Drug Administration Adverse Event Reporting System through December 6, 2019. PubMed and EMBASE were also searched for acute hyperkinetic movement reports with the concomitant use of ADHD stimulants-antipsychotics through January 13, 2020.
FINDINGS/RESULTS: We identified 36 cases resulting in acute hyperkinetic movement disorder associated with the concomitant use of ADHD stimulants-antipsychotics, 19 of which were also identified in the medical literature. From an ADHD stimulant perspective, methylphenidate products accounted for the largest number of cases (n = 23 [64%]), followed by amphetamine products (n = 9 [25%]) and atomoxetine (n = 4 [11%]). From an antipsychotic perspective, all 36 cases were reported with second-generation antipsychotics, particularly risperidone (n = 20 [56%]). Most of the cases were reported in boys (n = 31 [86%]) aged 6 to 12 years (n = 27 [75%]). Approximately 53% of the cases reported a time to onset within 24 hours of the drug change. Acute dystonic reactions (n = 27 [75%]) were the most frequently reported movement disorder.
IMPLICATIONS/CONCLUSIONS: As outlined in changes to the US prescribing information for all methylphenidate and risperidone products, health care professionals should be aware that changes to this combination may be associated with a pharmacodynamic drug-drug interaction resulting in acute hyperkinetic movement disorder.
目的/背景:在儿童和青少年中,同时使用注意力缺陷/多动障碍(ADHD)兴奋剂和抗精神病药已报告出现急性多动障碍。我们分析了与同时使用 ADHD 兴奋剂和抗精神病药相关的疑似急性多动障碍的上市后报告。
方法/程序:我们在美国食品和药物管理局不良事件报告系统中搜索了与同时使用 ADHD 兴奋剂-抗精神病药相关的急性多动障碍的上市后报告,截至 2019 年 12 月 6 日。还通过 2020 年 1 月 13 日在 PubMed 和 EMBASE 上搜索了与同时使用 ADHD 兴奋剂-抗精神病药相关的急性多动报告。
结果/发现:我们确定了 36 例与同时使用 ADHD 兴奋剂-抗精神病药相关的急性多动障碍病例,其中 19 例也在医学文献中得到确认。从 ADHD 兴奋剂的角度来看,哌醋甲酯产品占病例数最多(n = 23 [64%]),其次是安非他命产品(n = 9 [25%])和阿托西汀(n = 4 [11%])。从抗精神病药的角度来看,所有 36 例均报告使用第二代抗精神病药,特别是利培酮(n = 20 [56%])。大多数病例报告发生在 6 至 12 岁的男孩(n = 31 [86%])中。大约 53%的病例报告药物改变后 24 小时内出现发病。急性肌张力障碍反应(n = 27 [75%])是最常报告的运动障碍。
含义/结论:正如所有哌醋甲酯和利培酮产品的美国处方信息变更中所述,医务人员应意识到这种组合的变化可能与导致急性多动障碍的药效学药物-药物相互作用有关。