ST LOUIS (MD Consult) - On May 5, 2009, the US Food and Drug Administration (FDA) announced that it has approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (eg, migraine and neuropathic pain syndromes). In addition, the FDA is also requiring manufacturers to develop a patient medication guide that is to be issued each time one of the affected products is dispensed.

Since issuing safety alerts for antiepileptic drugs on December 16, 2008, and January 31, 2008, the FDA has been working with drug manufacturers to better understand the suicidality risk associated with their use. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the 11 drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.

Health care professionals are being advised to closely monitor all patients currently taking or starting any antiepileptic drug. Providers should be alert for patients who exhibit notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses are the following (some of these drugs are also available in generic form):

• carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR);
• felbamate (marketed as Felbatol);
• gabapentin (marketed as Neurontin);
• lamotrigine (marketed as Lamictal);
• levetiracetam (marketed as Keppra);
• oxcarbazepine (marketed as Trileptal);
• pregabalin (marketed as Lyrica);
• tiagabine (marketed as Gabitril);
• topiramate (marketed as Topamax);
• valproate (marketed as Depakote, Depakote ER, Depakene, Depacon); and
• zonisamide (marketed as Zonegran).

Although the 11 drugs listed above were the ones included in the analysis, the FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.
 

圣路易斯（MD Consult）——2009年5月5日，美国FDA宣布，其已经批准治疗癫痫、精神障碍及其他疾病（如偏头痛和神经性疼痛综合征）的抗癫痫药物的新标签。另外，FDA还要求生产厂家制定一份用药指南随上述药品发放。

自从2008年12月16日和2008年1月31日FDA发布抗癫痫药物安全性警告以来，FDA与生产厂家一起对与使用上述药物相关的自杀危险进行了研究。对应用11种抗癫痫药治疗癫痫、精神障碍和其他疾病的安慰剂对照临床研究进行汇合分析，结果发现，尽管作用机制和适应证不同，但这11种药物导致自杀意念及自杀行为的危险性基本一致。该研究提示，抗癫痫药物用于任何适应证治疗时均具有致自杀危险性。

FDA告诫医务人员，应严密监视正在使用或开始使用抗癫痫药物的患者。医务人员应警惕患者的明显行为改变，因为这可能表明患者有自杀意念、自杀行为或抑郁情况出现或加重。

纳入分析的抗癫痫药包括（有些药物已有仿制药上市）：

卡马西平（商品名Carbatrol、Equetro、Tegretol和Tegretol XR）
非尔安酯（商品名Felbatol）
加巴喷丁（商品名Neurontin）
拉莫三嗪（商品名Lamictal）
左乙拉西坦（商品各Keppra）
奥卡西平（商品名Trileptal）
普加巴林（商品名Lyrica）
噻加宾（商品名Gabitril）
托吡酯（商品名Topamax）
丙戊酸盐（商品名Depakote、Depakote ER、Depakene和Depacon）
唑尼沙胺（商品名Zonegren）

FDA指出，虽然仅对上面列出的11种药进行分析，但所有抗癫痫药都可能存在增加患者自杀意念和企图的危险，将会对此类药的标签进行普遍修改。

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