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Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration
AUDIENCE: Health Professional, Neurology, Patient
ISSUE: FDA is warning the public that the anti-seizure medication Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. FDA does not currently know if these changes are reversible. 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.
BACKGROUND: Potiga is approved as adjunctive (added on to other anti-seizure medications) treatment of partial-onset seizures in adult patients 18 years and older. 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. In some cases, retinal abnormalities have been observed in the absence of skin discoloration.
RECOMMENDATION: All patients taking Potiga should have a baseline eye exam and periodic eye exams that should include visual acuity testing and dilated fundus photography, and may include fluorescein angiograms (FA), ocular coherence tomography (OCT), perimetry, and electroretinograms (ERG). Patients who are taking Potiga and develop any changes in your vision or any discoloration of your skin, including of your lips and nail beds should contact their health care professional right away. Patients should not stop taking Potiga without talking to their health care professional. Stopping such treatment suddenly can cause serious and life-threatening medical problems such as recurrence of seizures.
Read the MedWatch Safety Alert, including links to the Drug Safety Communication at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA告知大眾，抗癲癇藥物Potiga (ezogabine)可能會造成皮膚及視網膜的色素異常。FDA尚未確認此症狀是否能因停藥而改善。FDA正與廠商一同評估所有資訊以深入了解此事件之原因，若有最新訊息將告知大眾。
Potiga核准使用於18歲以上成人局部癲癇之輔助性治療。依據呈報之個案所示，病人主要於嘴唇周圍與手指或腳趾之甲床出現藍色色素沉積，也有延伸至臉 部與四肢之報告。眼睛部份，鞏膜、結膜、眼白及眼瞼內側皆有顏色變化之報告。此皮膚色素異常現象普遍出現於已服用Potiga 4年以上之病人，但部分病人更早便出現症狀。也有僅發生視網膜異常之案例。
所有正服用Potiga之病人應定期接受眼部檢查，包含視力檢查，螢光眼底攝影(FA)、光學同調斷層掃描(OCT)、視野檢查及視網膜電波圖 (ERG)。服藥之病人若發現任何視覺改變或皮膚色素異常，包含嘴唇及甲床，請立即與醫療專業人員連絡。病人在尚未告知醫療人員前請勿自行停止服藥，擅自 停藥可能會導致嚴重且危及生命如癲癇復發等風險發生。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
[Posted 04/26/2013]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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資料來源：藥師週刊（第1821期）
