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Intravitreal Injection and Quantitation of Infection Parameters in a Mouse Model of Bacterial Endophthalmitis
Published on: February 6, 2021
Fungal endophthalmitis associated with compounded products
Abstract:
Fungal endophthalmitis is a rare but serious infection. In March 2012, several cases of probable and laboratory-confirmed fungal endophthalmitis occurring after invasive ocular procedures were reported nationwide. We identified 47 cases in 9 states: 21 patients had been exposed to the intraocular dye Brilliant Blue G (BBG) during retinal surgery, and the other 26 had received an intravitreal injection containing triamcinolone acetonide. Both drugs were produced by Franck's Compounding Lab (Ocala, FL, USA). Fusarium incarnatum-equiseti species complex mold was identified in specimens from BBG-exposed case-patients and an unopened BBG vial. Bipolaris hawaiiensis mold was identified in specimens from triamcinolone-exposed case-patients. Exposure to either product was the only factor associated with case status. Of 40 case-patients for whom data were available, 39 (98%) lost vision. These concurrent outbreaks, associated with 1 compounding pharmacy, resulted in a product recall. Ensuring safety and integrity of compounded medications is critical for preventing further outbreaks associated with compounded products.
Insights
Outbreaks of fungal endophthalmitis occurred after eye procedures due to contaminated compounded medications. These infections, linked to Brilliant Blue G dye and triamcinolone acetonide, led to widespread vision loss and product recalls.
Area of Science:
- Ophthalmology
- Infectious Diseases
- Public Health
Background:
- Fungal endophthalmitis is a severe ocular infection.
- In March 2012, a national outbreak of fungal endophthalmitis was identified following invasive ocular procedures.
Purpose of the Study:
- To investigate the cause of concurrent fungal endophthalmitis outbreaks.
- To identify the source and associated risk factors for these infections.
Main Methods:
- Retrospective case-control study involving 47 patients across 9 states.
- Microbiological analysis of patient specimens and compounded drug products.
- Epidemiological investigation to determine exposure and risk factors.
Main Results:
- Two distinct outbreaks were identified, linked to a single compounding pharmacy.
- One outbreak involved Brilliant Blue G (BBG) dye (Fusarium incarnatum-equiseti complex), the other triamcinolone acetonide (Bipolaris hawaiiensis).
- Exposure to either compounded product was the sole identified risk factor; 98% of affected patients experienced vision loss.
Conclusions:
- Contaminated compounded medications pose a significant risk for serious ocular infections.
- Ensuring the safety and integrity of compounded pharmaceuticals is crucial for preventing patient harm.
- These outbreaks necessitated product recalls and highlighted the need for stringent regulatory oversight.
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