FDA正在仔细评估已批准的治疗儿童咳嗽的处方阿片类药物

Statementfrom FDA Commissioner Scott Gottlieb, M.D. – FDA is carefully evaluatingprescription opioid medicati** approved to treat cough in children

FDA正在仔细评估已批准的治疗儿童咳嗽的处方阿片类药物

ForImmediate Release

August 21, 2017

Statement

声明

There’sperhaps no more important mandate that we have at the FDA than safeguading thehealth and safety of children. For that reason, I believe it’s important thatparents and health care providers have the best imformation available to informthe decisi** they make about a child’s health. Thereare few more common decisi** that parents and providers are asked to make thanthe question of how to appropriately treat a child’s cough and cold symptoms.Sometimes symptoms can be severe enough that prescription medication is needed,but some of these medicati** pose their own risks – especially for younger children– because they may contain opioids. Other times medication might not benecessary at all.

在FDA，也许没有比保护儿童健康和安全更重要的任务了。因此，我认为家长和卫生服务提供者拥有最好的的信息来告知他们对孩子的健康做出的决定是很重要的。家长和卫生服务提供者被要求做出的决定要比如何恰当地治疗孩子的咳嗽和感冒症状的问题更常见。有时候症状已经严重到需要使用处方药物，但是这些药物中的一些药物有它们自身的风险-特别是对于年幼的儿童来说-因为它们可能含有阿片类药物。其他时候，药物可能根本不是必要的。

At aroundtable earlier this year, the FDA heard from professional groups, includingthe American Academy of Pediatrics and the American Academy of FamilyPhysicians, about the use of cough suppressants, and in particular opioid coughsuppressants, in children. Some of the key points focused on determining theright treatment based on the length and severity of the symptoms, as well astreating what’s causing the symptoms, rather than just quieting the cough. Anddepending on the situation, representatives suggested that other medicati** ornon-drug therapies may be more appropriate.

在今年早些时候的圆桌会议中，FDA收到了专家团队的来信，包括美国儿科学会和美国家庭医生学会，内容是关于止咳药物的使用，特别是阿片类止咳药对儿童的使用。有一些关键点，根据症状的长短和严重程度，关注于确定正确的治疗方法以及治疗引起症状的原因，而不是仅仅平息咳嗽。根据情况，代表人建议其他一些药物或者非药物治疗方式可以更合适。

Tomore carefully c**ider this complex issue, the FDA today announced an upcomingmeeting of the Pediatric Advisory Committee that will focus on the use ofprescription opioid products containing hydrocodone or codeine for thetreatment of cough in pediatric patients, including current treatment practicesand benefit-risk c**iderati**. The panel of independent experts will providevaluable input to help inform the agency’s decision-making processes related tothese medicati**.

为更仔细的考虑这个复杂的问题，FDA今天宣布一个即将召开的儿科顾问委员会会议，该会议的关注点是为治疗儿童病患咳嗽，含氢可酮或可待因处方类阿片药物的使用情况，包括目前的治疗措施及其注意事项。独立专家小组将提供有价值的信息，帮助告知该机构与这些药物相关的决策过程。

It isvital we understand the potential complicati** that can occur when usingopioid-containing medicati** in children, even according to labeledinstructi**. This is an area that the agency is continuing to evaluate. As partof these efforts, the FDA announced required changes in April 2017 to thelabeling of prescription codeine products in order to help better protectchildren from serious risks associated with these opioid medicati**, includinglife-threatening respiratory depression and death. Those changes include addinga contraindication to drug labels alerting that codeine should not be used forany reason, including treatment of cough, in children younger than 12 years.

当儿童使用含类阿片成分药物，甚至是根据说明书建议使用的时候，了解其潜在的并发症是非常重要的。这也是监管机构正在持续评估的领域。作为这些努力的一部分，FDA在2017年7月宣布要求对处方可待因产品的标签进行变更，以便有助于更好的预防儿童受到与这些阿片类药物相关的严重风险的影响，包括危及生命的呼吸衰竭和死亡。这些变更中包括对药品标签增加禁忌症-警告不可因任何理由使用可待因，包括治疗12岁以下儿童的咳嗽。

TheFDA has also provided tips for c**umers on how to safely treat a child’s coldas most young children do not need medicines to treat a cough or cold.Caregivers should read labels on non-prescription cough and cold products thatmay be sold over the counter as these products may contain codeine or may notbe appropriate for young children. The FDA is also funding research to developcomprehensive, c**umer-centered approaches on best practices for the safe useof pediatric cough and cold medicati** generally – not just those that containan opioid.

FDA也为消费者提供了如何治疗儿童感冒的小技巧，因为对于大多数的幼儿来说，不需要使用药物来治疗咳嗽和感冒。护理人员应该阅读由柜台出售的非处方咳嗽和感冒药物的标签，因为这些产品可能含有可待因或者可能不适用于幼儿。FDA也在资助研究，以开发综合的、以消费者为中心的方法，针对儿童咳嗽和感冒药物的安全使用的最佳做法，而不仅仅是那些含有阿片类的药物。

Allof this work is essential to reducing preventable harm from opioid-containingmedicati** and keeping children safe. We look forward to a robust discussionat the meeting this fall and will continue to share updates with the public onthe steps the agency is taking to address this important issue.

所有这些工作对于减少由阿片类药物所造成的可预防的伤害和保护儿童安全是至关重要的。我们期待在今年秋天的会议上有一个强有力的讨论，并将继续与公众分享有关部门正在采取的措施，以解决这个重要问题。

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