FDAが抗けいれん薬による自殺のリスクを認めました

 FDA Advisory Members Agree Antiepileptics Pose Suicidality Risk, Nix Need for Black-Box Warning
http://www.medscape.com/viewarticle/577432_print
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FDAのサイトの記載は下記で今年の1/31/2008のFDA警告
http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm
Information for Healthcare Professionals
Suicidality and Antiepileptic Drugs
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FDA ALERT [1/31/2008]:  The FDA has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. 
FDAはてんかんやその他の精神疾患および疾患の治療に使われる１１の抗けいれん薬の自殺（自殺行動と希死念慮）のプラセボ対照試験試験を分析しました。
These drugs are commonly referred to as antiepileptic drugs (see the list below).
これらの薬は抗けいれん薬（抗てんかん薬）と通常よばれます。
 In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). 
FDAの分析では，抗けいれん薬を飲んでいる患者は，プラセボを摂った患者の約2倍の自殺行動と自殺念慮のリスク (0.43%対0.22%)がありました。
The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. 
自殺のリスクの増加は，抗けいれん薬を飲んで早くて1週間から始まり，24週までは続きます。結果は11種の抗けいれん薬で一致していました。
Patients who were treated for epilepsy, psychiatric disorders, and other conditions were all at increased risk for suicidality when compared to placebo, and there did not appear to be a specific demographic subgroup of patients to which the increased risk could be attributed. 
てんかん患者，精神疾患患者，その他の疾患患者とも，プラセボに比して自殺が増え，特別な集団で見られるわけではなかった。
The relative risk for suicidality was higher in the patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions. 
ただ自殺の相対危険度はてんかんで他の疾患に比べて高かった。

All patients who are currently taking or starting on any antiepileptic drug should be closely monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression. 
現在，抗けいれん薬を服用しているか，開始しようとしている患者は，注意深く観察して，行動の変化，自殺念慮・行動，うつ状態の出現・悪化を見守る必要があります。

This information reflects FDA’s current analysis of available data concerning these drugs.  Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue.  Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA intends to update this document when additional information or analyses become available.

11 Antiepileptic Drugs Analyzed by the FDA Drug 
Carbamazepine(テグレトール), Felbamate, Gabapentin, Lamotrigine, Levetiracetam, Oxcarbazepine, Pregabalin,  Tiagabine,  Topiramate, 

Valproate(デパケン）,  Zonisamide