文章来源：FDA网站 发布时间：2014-06-24 09:35:50 浏览次数：
FDA发布多西他赛可能导致乙醇中毒
美国食品和药品管理局（FDA）于2014年6月20日发布信息，静脉应用含有乙醇成分的多西他赛化疗期间或治疗后可能导致患者出现醉酒或乙醇中毒表现。FDA正在要求多西他赛所有产品修订标签以警示该风险。医务人员给予患者应用此类产品时应考虑其中所含的乙醇成分对中枢神经系统的影响。患者也应对此提高警惕，并应在输注多西他赛1~2小时内避免开车、操作机械及进行其他危险性活动。另外，某些镇痛药物和安眠药物也可能与多西他赛中乙醇成分相互作用，造成更严重的不良反应。多西他赛为多种肿瘤化疗药物，可用于乳腺、前列腺、胃、头颈部肿瘤，以及非小细胞肺癌的化疗。不同规格的多西他赛所含乙醇含量各不相同。医务人员应对其进行监测并对患者进行风险告知。
Safety Announcement
[[6-20-2014] The U.S. Food and Drug Administration (FDA) is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. We are revising the labels of all docetaxel drug products to warn about this risk. Health care professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications.
Patients should be aware that docetaxel may cause them to become intoxicated from the alcohol it contains. Patients should avoid driving, operating machinery, or performing other activities that are dangerous for one to two hours after the infusion of docetaxel. In addition, some medications, such as pain relievers and sleep aids, may interact with the alcohol in the docetaxel infusion and worsen the intoxicating effects.
Docetaxel is a prescription chemotherapy drug used to treat different kinds of cancer, including cancers of the breast, prostate, stomach, head and neck cancers, and non-small-cell lung cancer. Several forms of docetaxel are currently marketed, including generics and the brand-name products Taxotere, Docefrez, and Docetaxel Injection. The various products contain different amounts of alcohol, which is used to dissolve the active ingredients so docetaxel can be given intravenously (see Docetaxel Formulations and Alcohol Content). Health care professionals should be aware of the differences in formulations in order to monitor and counsel patients appropriately.