FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.
FDA 要求常规抗精神病药物增加黑框警示
美国FDA今天行使《2007年度食品药品管理法修正案》（FDAAA）赋予的新权力，要求制药商对“常规”抗精神病药物的处方信息或标签进行安全性相关变更，以警告这些药物在治疗老年痴呆患者行为紊乱时，超出许可使用范围可能增加死亡的风险。
In 2005, the FDA announced similar labeling changes for "atypical" antipsychotic drugs. At that time, Boxed Warnings, the FDA's strongest, were added. The Boxed Warning will now be added to an older class of drugs known as "conventional" antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.
2005年FDA曾就非典型抗精神病药物宣布过类似的标签变更，那一次加入了黑框警示和FDA最强调部分。现在黑框警示将加到一种老药物——常规抗精神病药物。警告说，临床研究表明这两种类型药物用于老年痴呆相关精神疾病时会增加死亡的危险。
"It is important that health care professionals and consumers have the most up-to-date drug safety information," said Thomas Laughren, M.D., director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research. "The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia."
“医疗护理人员和消费者获取最新药物安全信息是非常重要的”，Thomas Laughren, 医学博士，FDA药物评估和研究中心精神产品部负责人说。“所有抗精神病药物的处方信息将及时更新，描述治疗老年痴呆症患者时的死亡危险。”
Antipsychotic drugs commonly are categorized into two classes, the older "conventional" antipsychotics and the newer "atypical" antipsychotics. Both classes of drugs are dopamine receptor antagonists that work by blocking the action of naturally occurring dopamine in the brain. They differ primarily in their side effects, with the atypical drugs having a lower incidence of neurological side effects such as involuntary movements or "tics."
抗精神病药物通常分为两类，老的“常规”和新的“非典型” 抗精神病药物。两类药物都多巴胺受体拮抗剂，通过阻断大脑自然发生的多巴胺活性发挥效用。区别在于两者的副作用，非典型类发生神经副作用更低，比如无意识运动或抽搐。
Neither class of antipsychotic is FDA-approved for use in the treatment of dementia-related symptoms, which can include forgetfulness, poor memory, and an inability to recognize familiar objects, sounds, or people. The drugs are FDA-approved primarily for the treatment of symptoms associated with schizophrenia. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called "off-label" use and falls within the practice of medicine.
FDA没有批准任一类抗精神病药物用于治疗痴呆相关症状，包括遗忘，记忆力差，不能认知熟悉事务，声音和人。FDA批准这些药物主要用于精神分裂症。而是否用于治疗痴呆相关症状则由医生决定。这类应用常被称为药物许可适应症以外的使用方式。
Recently, two observational epidemiological studies were published that examined the risk of death in elderly patients with dementia who were treated with conventional antipsychotic drugs. The investigators compared the risk for death with use of an atypical antipsychotic versus either no antipsychotic or the use of a conventional antipsychotic. These studies have limitations that preclude reaching a definitive conclusion about comparative death rates for atypical and conventional antipsychotic drugs. Nevertheless, the FDA has concluded that these studies, along with the earlier evidence for atypical antipsychotic drugs, suggest that both classes of drugs should be considered to have an increased risk of death when used in elderly patients treated for dementia-related psychosis.
最近，两项流行病学观察研究公布了通过研究应用常规抗精神病药物治疗痴呆老年病人的死亡危险率的结果。调查者对使用非典型抗精神病药物，不用抗精神病药物，使用常规抗精神病药物的死亡危险进行了比较。这些研究有限制排除关于比较非典型和常规药物死亡率的明确的结论。无论如何，FDA已经断定，这些研究，结合早些时候非典型药类的证据，建议两种药物都应考虑在用于治疗老年人痴呆症状时可能增加死亡危险。
An explanation of the data and advice for treating patients is available in an FDA notice to health care professionals being issued today.
向医疗护理人员提供的有关患者用药数据的解释和建议今天发布于FDA公告。
The FDA today issued letters to the manufacturers of both types of antipsychotic drugs, under the new authority of FDAAA, notifying the manufacturers that they should make changes to drug labeling. Manufacturers of both classes of drugs are being asked to change labeling so that all of the drugs carry uniform warning language. Manufacturers of these drugs are required to submit new language to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.
FDA今天借助FDAAA的新权威向两类抗精神病药物制造商发出通知，告知制造商对药物标签进行变更。两类药物制造商被要求改变标签，确保所有药物一律带有相同警告文字。这些药物制造商被要求30天内向FDA提交新文字，或者提供说明理由为什么他们认为不相信改变标签是必要的。如果他们不提供新文字，FDAAA提供严格的时限解决事务，必要的话允许管理部门启动强化行动。
People taking antipsychotic drugs should not abruptly stop taking them. Caregivers and patients should talk to the patient's health care professionals about any concerns.
服药者应不要立即停用这些药物，有关问题应与专家讨论。
The medications involved in this action are:
涉及药物有：
常规抗精神病药物 非典型抗精神病药物
Compazine (丙氯拉嗪) Abilify (阿立哌唑)
Haldol (氟哌啶醇) Clozaril (氯氮平)
Loxitane (洛沙平) FazaClo (氯氮平)
Mellaril (甲硫达嗪) Geodon (齐拉西酮)
Moban (molindrone) Invega (帕潘立酮)
Navane (thithixene) 利培酮（利培酮）
奥拉普（匹莫齐特） 思瑞康（喹硫平）
Prolixin (氟奋乃静) Zyprexa (奥氮平)
Stelazine (三氟) Symbyax (奥氮平与氟西汀)
Thorazine (氯丙嗪)
Trilafon (奋乃静)
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