FDA Warns of Adverse Event with Intraocular Injections of Triamcinolone, Moxifloxacin, and Vancomycin

Washington, DC: The US Food and Drug Administration (FDA) has issued information on an adverse event report concerning a patient who was diagnosed postoperatively with bilateral hemorrhagic occlusive retinal vasculitis (HORV) resulting from injections of a compounded triamcinolone, moxifloxacin, and vancomycin (TMV) formulation. The patient developed HORV after being given injections in each eye at the end of cataract surgery procedures that were done two weeks apart.

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.

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.

Many ophthalmologists use intraocular vancomycin during cataract surgery with the intent of preventing postoperative endophthalmitis.

The FDA states in its notice that it is unaware of any adequately controlled studies demonstrating the safety and efficacy of intraocular vancomycin in preventing endophthalmitis. Further, 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 TMV formulation in the case report was compounded by Imprimis Pharmaceuticals, Inc, according the to the FDA statement.

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Published on Oct-4-17