Federal health officials indicate that ophthalmologists need to be cautious about problems associated with certain anti-inflammatory eye drops used after cataract surgery, after a patient was recently diagnosed with a rare and potentially blinding disease.
In a vancomycin eye injection warning issued on October 3, 2017, the FDA outlined an adverse event report received from a physician regarding a patient who developed bilateral hemorrhagic occlusive retinal vasculitis (HORV), which can cause blindness, after receiving anti-inflammatory eye injections after cataract surgery.
Patients who undergo cataract surgery are often given eye injections that consist of a compounded triamcinolone, moxifloxacin and vancomycin (TMV) formulation to prevent inflammation after eye surgery. However, the FDA warns that the injections are not proven to work, and no such injections have ever been approved by the FDA.
According to the FDA warning, an ophthalmologist filed an adverse health report with the agency on August 14, 2017 after the patient developed HORV following cataract surgery and injections of TMV. The TMV injection solutions are often prepared at the surgical site or obtained in advance from a compounding pharmacy.
HORV is a recently discovered condition associated with the use of certain anti-inflammatory injections following cataract surgeries. The condition has a delayed onset that can take up to three weeks for symptoms including decreased vision, inflammation of the eyes, bleeding of the retina, inflammation of the retinal vessels, blockage of the retinal vessels, and lack of sufficient blood supply to the retinal vessels.
In severe cases of HORV, patients have experienced those symptoms previously listed, as well as permanent blindness when vancomycin is administered is administered to both eyes.
According to the FDA, the TMV solution used on the affected patient was supplied by Imprimis Pharmaceuticals Inc., located in Ledgewood, New Jersey.
The TMV solutions are prepared based on need prior to the surgeries and are not prepackaged for distribution. Currently, the FDA is unaware of adequately controlled studies demonstrating the safety and efficacy of intraocular vancomycin in preventing endophthalmitis (inflammation), and has not issued any FDA approved vancomycin formulation standards for eye injections.