FDA：抗癫痫药依佐加滨或与视网膜病变和皮肤色素减退相关

（图片来源于FDA官网）

　　4月26日，美国食品与药物管理局（FDA）提醒公众，抗癫痫药物依佐加滨 （ezogabine）可引起皮肤色素减退和以视网膜颜色变化为特点的眼部异常。目前尚不清楚上述变化是否可逆。

　　FDA建议所有开始和正在服用依佐加滨的患者应进行基础和定期的眼部检查，如果患者出现了皮肤色素减退，即应改变治疗药物。患者在未咨询专业医疗保健人员的情况下，不应停止服用任何抗癫痫药。为更好地了解这些事件，FDA正和相关厂家合作收集和评估所有可利用信息，届时将通知公众。

　　视网膜变色有潜在导致失明的严重眼部疾病危险。虽然已报告 数个患者有视敏度的损害，但目前尚不清楚患者视力损害是否是由依佐加滨导致的视网膜变色所致。

　　已报告病例的皮肤色素减退主要以唇部及其周边或手足指甲床为主，但也更广泛见于脸部和腿部；同时也观察到患者眼部巩膜和结膜及眼睑内部有上述改变。皮肤色素减退一般常见于应用依佐加滨治疗后4年发生，但也有一些患者似乎更快发生。一些患者在出现皮肤色素减退后就已观察到视网膜异常。　

与癫痫相关的拓展阅读： 

• JAMA：产前服用抗癫痫药物丙戊酸钠增加儿童自闭症风险
• MDlinx：惊厥性癫痫持续状态对早期发育的影响
• MDlinx：吡仑帕奈，难治性继发性癫痫的治疗新选择
• Neurology：癫痫患者手术时机与病情严重度和非临床因素相关
• Neurology：外部三叉神经刺激对耐药性癫痫或有效 更多信息请点击：有关癫痫更多资讯

FDA Drug Safety Communication: Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discoloration
04-26-2013]  The U.S. Food and Drug Administration (FDA) is warning the public that the anti-seizure medication Potiga (ezogabine) can cause blue skin discoloration (See Photos) and eye abnormalities characterized by pigment changes in the retina. FDA does not currently know if these changes are reversible. All patients taking Potiga should have a baseline eye exam, followed by periodic eye exams. FDA is working with the manufacturer to gather and evaluate all available information to better understand these events. FDA will update the public when more information is available.

Pigment changes in the retina have the potential to cause serious eye disease with loss of vision. It is not yet known whether the retinal pigment changes caused by Potiga lead to visual impairment, although several patients have been reported to have impaired visual acuity.

The skin discoloration in the reported cases appeared as blue pigmentation, predominantly on or around the lips or in the nail beds of the fingers or toes, but more widespread involvement of the face and legs has also been reported. Scleral and conjunctival discoloration, on the white of the eye and inside eyelids, has been observed as well. The skin discoloration generally occurred after four years of treatment with Potiga, but has appeared sooner in some patients (See Data Summary). In some cases, retinal abnormalities have been observed in the absence of skin discoloration.

In light of this new safety information, all patients taking Potiga or about to start Potiga should have an eye exam, followed by periodic eye exams thereafter (See Information for Health Care Professionals).  Potiga should be discontinued if ophthalmic changes are observed unless no other treatment options are available.  If a patient develops skin discoloration, serious consideration should be given to changing to an alternate medication.

Patients should not stop taking Potiga or any anti-seizure medication without talking to their health care professional, as stopping anti-seizure treatment suddenly can precipitate withdrawal seizures, a serious and life-threatening medical problem.