主页 > 医学讨论 >
【drug-news】Cephalon 发出其镇痛药 Fentora的安全警告
Cephalon Pain Lozenge Flagged In Deaths
Posted by Jacob Goldstein
Cephalon, which has been criticized for inappropriately marketing its narcotic lollipop Actiq, has now sent this Dear Doctor letter to warn about troubling side effects of its painkiller Fentora.
The possible side effects have included four deaths, one of them a suicide, Dow Jones reports this afternoon. The drug has been prescribed 79,000 times since it was approved late last year in the U.S., according to data from WoltersKluwerHealth. Sales since it was introduced were about $122 million.
The Dear Doctor letter (and a similar Dear Healthcare Professional letter) says the problems have arisen because the drug was given at the wrong dose or prescribed to the wrong patients. It’s approved only for cancer patients who are already taking other painkillers but are still having bouts of breakthrough pain.
Fentora is a fast-acting form of fentanyl, which is also the active ingredient in Actiq, now a generic. Like Fentora, Actiq is approved only for use in cancer patients — but one analysis found that 80% of the patients who received Actiq didn’t have cancer, the WSJ reported last year.
In March, Rep. Henry Waxman (D-Calif.) sent this letter to Cephalon, citing allegations of “inappropriate marketing of narcotics” and requesting information on Actiq and Fentora. And today, the Connecticut attorney general sent out a press release that said “today’s report by Cephalon tragically confirms concerns raised by our aggressive investigation into Cephalon’s off-label marketing of its drugs.”
Cephalon spokeswoman Stacey Beckhardt told the Health Blog that the company “promotes its medications consistent with the labeled indication, but we are aware that there are some physicians who have prescribed our medications outside the approved labeling.” She noted that fentanyl is an old drug, familiar to many doctors, and added that “in the case of Fentora, today we are taking active steps to re-emphasize the importance of adhering to the labeling information.” 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。
第一次认领编译哈，译得不当之处，大家多指教 首先说一下，我不是特别清楚“Dear Doctor letter”这个怎么翻译，呵呵，汗……
初次试译，请大家帮助和指正：）
September 13, 2007, 4:40 pm
Cephalon Pain Lozenge Flagged In Deaths
塞法隆止痛药导致死亡等不良反应
Posted by Jacob Goldstein
Cephalon, which has been criticized for inappropriately marketing its narcotic lollipop Actiq, has now sent this Dear Doctor letter to warn about troubling side effects of its painkiller Fentora.
塞法隆制药公司曾经被责疑其不正当地销售棒棒糖样的麻醉药品Actiq（柠檬酸芬太尼）。现公司已发表其医师使用说明，警告镇痛药Fentora（芬太尼）具有严重副作用。
The possible side effects have included four deaths, one of them a suicide, Dow Jones reports this afternoon. The drug has been prescribed 79,000 times since it was approved late last year in the U.S., according to data from WoltersKluwerHealth. Sales since it was introduced were about $122 million.
道琼斯今日下午的报道称这种可能的副作用导致了4例病人死亡，包括一例自杀。根据WoltersKluwerHealth统计数据表明，药物自去年底在美国上市以来，已被应用于79，000例处方，据介绍销售总额约122百万美金。
The Dear Doctor letter (and a similar Dear Healthcare Professional letter) says the problems have arisen because the drug was given at the wrong dose or prescribed to the wrong patients. It’s approved only for cancer patients who are already taking other painkillers but are still having bouts of breakthrough pain.
医师使用说明（以及类似专业医师使用说明）称由于药物被不适宜地应用于相关病人以及不恰当的剂量已经使得不良反应增多。药物只应被应用于那些已经服用其他止痛药物而仍感到剧烈疼痛的癌症病人。
Fentora is a fast-acting form of fentanyl, which is also the active ingredient in Actiq, now a generic. Like Fentora, Actiq is approved only for use in cancer patients — but one analysis found that 80% of the patients who received Actiq didn’t have cancer, the WSJ reported last year.
Fentora（芬太尼）是一种见效快的芬太尼制剂，目前为止，芬太尼一般也被认为是柠檬酸芬太尼的主要活性成分。和芬太尼一样，柠檬酸芬太尼也只被允许应用于癌症病人。然而WSJ去年的一项分析表明80%接受柠檬酸芬太尼治疗的患者并非癌症病人。
In March, Rep. Henry Waxman (D-Calif.) sent this letter to Cephalon, citing allegations of “inappropriate marketing of narcotics” and requesting information on Actiq and Fentora. And today, the Connecticut attorney general sent out a press release that said “today’s report by Cephalon tragically confirms concerns raised by our aggressive investigation into Cephalon’s off-label marketing of its drugs.”
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-08-28 08:06
医学,生命科学网