ST LOUIS (MD Consult) - On June 15, 2009, the US Food and Drug Administration (FDA) announced to health care professionals that it is providing its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat attention-deficit/hyperactivity disorder (ADHD) in children. The study, funded by the FDA and the National Institute of Mental Health, compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly, with the use of stimulant medications in 564 children who died as passengers in motor vehicle accidents. The study's authors concluded that an association may exist between the use of stimulant medications and sudden death in healthy children.
The FDA was unable to conclude that the overall risk and benefit profile of stimulant medications used to treat ADHD in children has been affected by data from this study because of perceived limitations in the study's methodology. Furthermore, the FDA believes that this study should not serve as the basis for a decision to discontinue a child's stimulant medication. Parents should be encouraged to discuss concerns about the use of these medicines with the prescribing health care professional. Parents should also be instructed to observe for cardiovascular symptoms (eg, chest pain, shortness of breath, or syncope) in any child receiving stimulant medication treatment and to seek immediate medical attention if noted.
The FDA is continuing its review of the strengths and limitations of this and other epidemiologic studies that evaluate the risks of stimulant medications used to treat ADHD in children. In fact, the FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiologic study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009.
The FDA lists the following products in relation to this possible safety issue:
Focalin and Focalin XR (dexmethylphenidate HCl);
Dexedrine, Dexedrine spansules, Dextroamphetamine ER, and Dextrostat (dextroamphetamine sulfate);
Vyvanse (lisdexamfetamine dimesylate);
Desoxyn (methamphetamine);
Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate);
Adderall, Adderall XR (mixed salts amphetamine);
Cylert (pemoline), and;
various generics.
圣路易斯(MD Consult)—— 2009年6月15日，美国食品药品管理局(FDA)在《美国精神病学杂志》(American Journal of Psychiatry)上发表的一项研究结果认为，精神兴奋药物治疗注意力缺陷多动症(ADHD)患儿具有潜在风险。该研究由美国FDA及美国国立精神卫生研究院(NIMH)资助，对全美564例使用精神兴奋药物并发生猝死的健康儿童与564例使用精神兴奋药物并死于机动车交通事故的儿童进行了比较。该研究的作者得出结论认为，健康儿童使用精神兴奋药物和猝死之间可能存在相关性。
由于研究方法的局限，受研究数据的影响，美国FDA尚不能判断精神兴奋药物治疗ADHD患儿的整体风险和收益。此外，FDA认为，该研究不应成为决定停止患儿精神兴奋药物治疗的依据。应鼓励家长与医生探讨使用此类药物存在的问题，并指导家长观察患儿在接受精神兴奋药物治疗后是否出现胸痛、气短或晕厥等心血管症状，一旦发生应立即就医。
美国FDA正在继续审查该研究以及其他流行病学调查的优势及局限性，以评估精神兴奋药物治疗ADHD患儿的风险。事实上，美国FDA和美国保健政策研究机构(AHRQ)正资助一项大型流行病学研究，以提供关于多动症患儿精神兴奋药物治疗相关潜在风险的进一步数据资料。该研究的数据收集工作将在2009年底完成。
以下为FDA列出的可能存在安全隐患的药品：
Focalin、Focalin XR (盐酸右哌甲酯)；
Dexedrine、Dexedrine spansules 、Dextroamphetamine ER、Dextrostat (右旋苯丙胺硫酸盐)；
Vyvanse (二甲磺酸赖右苯丙胺)；
Desoxyn (甲基苯丙胺)；
Concerta、Daytrana、Metadate CD、Metadate ER、Methylin、Methylin ER、Ritalin、Ritalin-LA、Ritalin-SR(哌甲酯)；
Adderall、Adderall XR(安非他明混合盐)；
Cylert (匹莫林)；
以及各种仿制药。
