Name similarities prompt rebranding of GERD drug Kapidex to reduce dispensing errors
ST LOUIS (MD Consult) - On March 4, 2010, the US Food and Drug Administration (FDA) and Takeda Pharmaceuticals announced that Kapidex (dexlansoprazole), a proton pump inhibitor used for the treatment of gastroesophageal reflux disease (GERD) and related conditions, will undergo a name change in the interest of patient safety. The new trade name of the product will be Dexilant.
Several reports of dispensing errors have been generated since the approval of Kapidex in January 2009. These errors have occurred because confusion existed between Kapidex and the drugs known by the brand names Casodex (bicalutamide) and Kadian (morphine sulfate). Casodex is used for the treatment of advanced prostate cancer, whereas Kadian is an opioid analgesic used for the treatment of pain.
The formulation, indication, and approved dosages of Dexilant will remain the same as those for Kapidex. The markings on the capsules remain unchanged and their appearance will be identical to those marked under the Kapidex trade name.
Takeda anticipates that the newly named product Dexilant will be available near the end of April 2010. Persons responsible for ordering, stocking, and billing for the product should be aware that Dexilant will have a new National Drug Code number assigned to it.
圣路易斯(MD Consult)——2010年3月4日,美国食品药品管理局(FDA)和日本武田制药公司宣布,为了患者的安全,Kapidex(右旋兰索拉唑)——一种用于治疗胃食管反流性疾病(GERD)及相关疾病的质子泵抑制剂,将进行名称变更。其新商品名将为Dexilant。
自2009年1月Kapidex获准以来,已出现多份有关发药错误的报告。这些错误产生的原因为,Kapidex与商品名为Casodex (比卡鲁胺) 和 Kadian (硫酸吗啡)的药品之间存在混淆。Casodex用于治疗晚期前列腺癌,而Kadian是一种用于治疗疼痛的阿片类止痛药。
Dexilant的分子式、适应证及获准剂量将与Kapidex保持一致。胶囊上的标识仍保持不变,其外观将与Kapidex商品名下标注的完全相同。
武田公司预计,新命名的药品Dexilant将在2010年近4月底上市。负责该药品的订购、进货以及开单的人员应知道Dexilant将有一个新分配的国家药品代码号。
刘梅林 2012-2-1 北京大学第一医院老年内科
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