使用統合失調症治療薬後２１人死亡

A few weeks ago the Mainichi News on-line reported the following:

統合失調症治療薬:使用後に２１人死亡…販売開始５カ月で

毎日新聞　2014年04月17日　19時21分（最終更新　04月17日　20時20分）

　厚生労働省は１７日、統合失調症治療薬「ゼプリオン」の使用後に死亡した患者が昨年１１月の販売開始から５カ月で２１人に上ると発表した。いずれも薬との因果関係は不明だが、同省は製造販売元のヤンセンファーマ（東京都千代田区）に対し、複数の抗精神病薬を併用する不安定な患者への使用や過剰な投与をしないよう医師向けの添付文書を改訂し、医療機関に注意喚起するよう指示した。

　厚労省によると、この薬は肩などの筋肉に４週間に１回注射し、症状を抑える。今月１５日までに推計で約１万９００人が使用し、効果が長く持続するのが特徴という。

　製薬会社の市販後の調査で、今月１６日までに２０〜７０代の男女２１人が使用後に死亡していたことが判明。死因は心筋梗塞（こうそく）や肺炎、多臓器不全のほか、嘔吐（おうと）物による窒息や自殺などもあった。投与開始から死亡までの日数も数日から１００日以上のケースまであった。

　この薬は主に症状の安定した患者が対象だが、症状が悪化しているのに投与を始めたり、複数の抗精神病薬と併用していたりする事例もあった。投与量が過剰とみられるケースもあった。

　この薬は２０１２年末時点で６０以上の国と地域で使用されているが、今回ほど短期間に多数の死亡例が報告されたことはないという。【桐野耕一】

(試譯文)

On the 17^th (April) the Ministry of Health, Labor and Welfare announced that the number of patients who had died after using a schizophrenia curing medicine "Zepurion" went up to 21 people in five months after the sale was started in November last year. Although the causal relationship with the medicine was not known, the said Ministry directed the Janssen Pharmaceutical (Chiyoda-district Tokyo) as the manufacturing and selling agency to revise the doctor-oriented package leaflet so as to stop the administration of medication to patients who would become unstable when two or more anti-psychotics were used at the same time, and also to avoid excessive dosage; and directed that the medical institutions should be cautious.

According to the Ministry of Health, Labor and Welfare, this medicine was injected into the muscle, such as the shoulder, once in four weeks to suppress the condition. In estimation about 10,900 people had used it by the 15th of this month (April). A feature was that the effect would continue for a long time.

It became clear from the investigation that after marketing by the drug company up to the 16th of this month 21 men and women in their 20-70s had died after using it. The cause of death besides myocardial infarction (kousoku), pneumonia, and multiple organ failure, there were also suffocation by a vomiting (outo) object and suicide etc. Death incidents started from several days to 100 days or more after taking the medicine.

While this medicine was mainly for patient with stable symptoms, there were cases that medication began when the condition was getting worse, or two or more anti-psychotics were used together. There was also a case that an excessive dosage was given.

Although this medicine had been used in more than 60 countries and regions by the end of 2012, it was said that there was not many examples of large amount of death being reported within a short period of time, such as this time.

It is an interesting medical incident. The Japanese government is doing a good job in drawing doctors’ attention.