給予抗癌藥物之後5人死亡, “不能否定有因果關係”

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

抗がん剤投与後５人死亡 「因果関係否定できず」

12月10日 14時58分

ことし９月に販売が始まった抗がん剤を投与された患者のうち５人がこの３か月の間に死亡していたことが分かり、抗がん剤を販売する製薬会社は、薬の投与との因果関係が否定できないとして、医療機関に対し、慎重に投与するよう注意を呼びかけています。

東京・新宿区に本社がある製薬会社「サノフィ」によりますと、ことし９月に前立腺がんの抗がん剤「ジェブタナ」の販売を始め、今月３日までの３か月間におよそ２００人の患者に投与されましたが、およそ２０％に当たる４０人に「好中球」と呼ばれる白血球の一種が減少する症状が確認されたということです。
このうち６０代から７０代の患者５人は感染症などが原因で死亡し、いずれも薬の投与との因果関係が否定できないということです。
薬の添付文書には、「海外では好中球が減少して患者が死亡するケースが報告されている」として、感染症の症状がある患者には投与しないよう記載されています。
今回の事態を受け、サノフィは改めて医療機関に対し、薬を慎重に投与するよう注意を呼びかけています。
サノフィは「薬を投与した患者に対しては血液検査を頻繁に行うとともに発熱などの症状が出て何らかの感染症が疑われる場合には速やかに治療を行ってほしい」と話しています。

(試譯文)

It was found out that among the people who were given the anti-cancer drug which was on sale since September this year (2014), five patients had died in 3 months; the pharmaceutical company that sold this anti-cancer drug could not ruled out the deaths had a causal relation with the prescription of medicine, and appealed for attention among medical agencies so that it might be prescribed with care.

According to the pharmaceutical company “Sanofi" with its headquarters in Tokyo Shinjuku-district, since September of this year it started selling an anti-cancer drug  "Jebb dandelion” for prostate cancer and the drug was prescribed to approximately 200 patients in the 3 months until the 3^rd of this month (December). It was said that 40 people or approximately 20 % was confirmed to have a symptom that showed a decrease in one type of leukocyte, the so called “neutrophil".

Among the patients, five of them aged from sixties to seventies were dead because of an infection etc., and it was said that a causal relation with medicine prescription could not be ruled out.

In the document attached to the medicine, it mentioned that "in foreign countries there were reported cases that patients with decreases in neutrophil have died", as such it should not be prescribed to a patient with symptoms of infection.

Noting this situation Sanofi once more appealed to medical agencies for attention so that the medicine might be applied carefully.

Sanofi was saying that "as well as frequently doing a blood test on the patient who has been give the medicine, when a fever comes out which is suspected to be some kind of infection symptom, to treat it promptly is expected".

    I hope all medical agencies that have prescribed this anti-cancer drug will exercise care in noting symptoms of infection in the patient.