Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis
AUDIENCE: Opthalmology, Pharmacy
ISSUE: FDA received an adverse event report on August 14, 2017, from a physician concerning a patient who was diagnosed postoperatively with bilateral hemorrhagic occlusive retinal vasculitis (HORV) after being administered injections of a compounded triamcinolone, moxifloxacin, and vancomycin (TMV) formulation in each eye at the conclusion of cataract surgery procedures that were done two weeks apart. The TMV formulation was compounded by Imprimis Pharmaceuticals, Inc., located in Ledgewood, New Jersey.
HORV is a rare, potentially blinding postoperative complication that has been observed in dozens of patients who have received intraocular injections of vancomycin (anti-infective) formulations toward the end of otherwise uncomplicated cataract surgeries.
BACKGROUND: Many ophthalmologists use intraocular vancomycin during cataract surgery with the intent of preventing postoperative endophthalmitis. FDA is unaware of any adequately controlled studies demonstrating the safety and efficacy of intraocular vancomycin in preventing endophthalmitis. There is no FDA-approved vancomycin formulation for intraocular injection. The formulation is usually prepared at the surgical site or obtained in advance of surgery from a compounding pharmacy.
The use of intraocular vancomycin has recently been associated with the newly described condition HORV. Characteristics of HORV include a delayed onset (up to three weeks) of sudden painless decreased vision, intraocular inflammation, intraretinal hemorrhage (bleeding within the retina), retinal vasculitis (inflammation within retinal vessels), vascular occlusion (blockage of retinal vessels), and retinal ischemia (lack of sufficient blood supply to the retina). If vancomycin is administered to both eyes, legal blindness is a likely consequence of HORV.
No cases of HORV were reported in a retrospective analysis of medical records of 922 patients (1541 eyes) who underwent cataract surgeries with intravitreal injections of compounded TMV formulations from November 2013 to December 2015. However, this chart review of non-controlled data is limited in its ability to identify rare events and may not necessarily be generalizable to a larger population who may undergo cataract surgery. The adverse event being reported here serves as a reminder that intraocular administration of vancomycin, including when the vancomycin is one of multiple active ingredients in a compounded drug, can result in HORV.
RECOMMENDATION: The prophylactic use of intraocular vancomycin, alone or in a compounded drug combining multiple active ingredients, during cataract surgery is generally not recommended because of the risk of HORV.
Read the MedWatch Safety Alert, including a link to the FDA Statement, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm578743.htm
美國FDA於2017年8月收到一則不良反應通報，一名病人於白內障手術給予triamcinolone, moxifloxacin, and vancomycin (TMV)之三合一注射劑於雙眼，兩週後診斷為手術後雙側出血性阻塞視網膜血管炎(hemorrhagic occlusive retinal vasculitis (HORV))。此TMV之三合一注射劑為美國紐澤西一家藥廠所製。
許多眼科醫師於白內障手術中，使用眼內注射vancomycin，是為了預防手術後的眼內炎(endophthalmitis)。而HORV為一罕見、可能會導致失明之術後併發症，曾於數十名病人於白內障手術給予眼內注射之vancomycin後發生。美國FDA尚未搜尋到任何適合的研究評估眼內注射vancomycin於預防眼內炎之效果與安全性，目前也未有美國FDA核可之vancomycin眼內注射之劑型，現階段臨床使用之vancomycin眼內注射皆為手術房配製或於術前於藥局調製。
HORV目前已被認為與眼內注射vancomycin相關，HORV可能會延遲至術後三週才出現，其症狀可能包含突然視力下降、眼內發炎、視網膜出血、視網膜血管炎、視網膜血管堵塞以及視網膜缺血等。如果雙眼皆給予vancomycin，若出現HORV即有可能造成失明。
目前回溯性分析2013年11月至2015年12月，922個病人(共1541隻眼睛)其使用TMV三合一注射劑於白內障手術之病歷紀錄並無HORV之相關案例報導。然而病歷回顧的方式無對照組，無法有效區分此罕見不良反應，也無法合理推斷此結論適用於其他白內障手術的病人族群。因此此則不良反應通報案例，僅能提醒醫療專業人員眼內注射vancomycin或是任何包含vancomycin之複方注射劑可能導致HORV之發生，故一般不建議於白內障手術中預防性使用眼內注射vancomycin或包含vancomycin之複方注射劑。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm578743.htm
[Posted 10/03/2017]
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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