FDA Warns that Vancomycin Eye Injections May Lead to Blindness

October 6, 2017: By Joan McKenna

1 Ophthalmic NewsVancomycin injections during eye surgery can lead to hemorrhagic occlusive retinal vasculitis (HORV), a rare, potentially blinding postoperative complication, the FDA warned Oct. 3 in a compounding risk alert to health care providers.

The agency said it received an adverse event report Aug. 14, 2017, for a patient who developed bilateral HORV after being administered injections of a compounded triamcinolone, moxifloxacin, and vancomycin (TMV) formulation in each eye at the conclusion of cataract surgeries performed two weeks apart. The TMV formulation was compounded by Imprimis Pharmaceuticals at its outsourcing facility in Ledgewood, New Jersey.

The FDA said symptoms of HORV include a delayed onset of sudden painless decreased vision, intraocular inflammation, intraretinal hemorrhage, retinal vasculitis, vascular occlusion, and retinal ischemia.

At the 2016 AAO meeting, Dean Eliott, MD, said HORV is suspected to be a rare type III hypersensitivity to vancomycin, but its exact cause and pathogenesis remain unproven.

The FDA said many ophthalmologists use intraocular vancomycin during cataract surgery to prevent postoperative endophthalmitis.

The agency said there is no US-approved vancomycin formulation for intraocular injection, and it is unaware of any adequately controlled studies demonstrating the safety and efficacy of vancomycin in preventing endophthalmitis.

The formulation is usually prepared at the surgical site or obtained in advance of surgery from a compounding pharmacy.

The agency concluded that prophylactic use of vancomycin, alone or in a compounded combination drugs, during cataract surgery is generally not recommended due to the risk of HORV.

The FDA said that, if vancomycin is administered to both eyes, patients with HORV likely will wind up legally blind.

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