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1关键词:依佐加滨(Potiga,Ezogabine)视网膜异常皮肤的蓝色脱色反应11/01/2013FDA批准修改药品标签以强调会造成视网膜异常,可能致失明以及皮肤变色,并且这些改变都可能是不可逆的。由于有视网膜异常的风险,修改过的标签包含了一个新的黑框警告。FDA建议减少Potiga的使用,仅用于其他可选择的治疗方法不能降低癫痫发作频率,或癫痫发作,并且治疗的收益大于风险的患者。FDA向公众警示,抗癫痫药依佐加滨(Potiga,Ezogabine)可能导致皮肤的蓝色脱色反应和以视网膜色素改变为特征的眼部异常。FDA目前尚不清楚这种改变是否可逆。FDA正与生产企业共同评价所有可用的信息以更好地认识这些事件。如有任何进展,FDA会及时向公众更新信息。
1 Keywords: Blue Decolorization of Retina Abnormal Skin in Potiga (Ezogabine) 11/01/2013 FDA approves modification of drug label to emphasize retinal abnormalities that may cause blindness and discoloration of the skin, and these changes are likely to be irreversible. The modified label contains a new black box warning due to the risk of retinal abnormalities. FDA recommends reducing the use of Potiga only for patients whose alternative treatments do not reduce the frequency of seizures, or seizures, and the benefits of treatment outweigh the risks. The FDA warned the public that the antiepileptic drug Potiga (Ezogabine) may cause a blue decolorization of the skin and ocular abnormalities characterized by retinal pigmentosis. It is not clear at this time that the change is reversible. FDA is working with manufacturing companies to evaluate all available information to better understand these events. In case of any progress, FDA will promptly update the public with the information.