Fungal Endophthalmitis Associated with Compounded Products - Volume 20, Number 2—February 2014 - Emerging Infectious Disease journal - CDC
Volume 20, Number 2—February 2014
Fungal Endophthalmitis Associated with Compounded Products
Christina A. Mikosz1, Rachel M. Smith1, Moon Kim, Clara Tyson, Ellen H. Lee, Eleanor Adams, Susanne Straif-Bourgeois, Rick Sowadsky, Shannon Arroyo, Yoran Grant-Greene, Julie Duran, Yvonne Vasquez, Byron F. Robinson, Julie R. Harris, Shawn R. Lockhart, Thomas J. Török, Laurene Mascola, Benjamin J. Park , and for the Fungal Endophthalmitis Outbreak Response Team
Author affiliations: Centers for Disease Control and Prevention, Atlanta, Georgia, USA (C.A. Mikosz, R.M. Smith, Y. Grant-Greene, B.F. Robinson, J.R. Harris, S.R. Lockhart, T.J. Török, and B.J. Park); Los Angeles County Department of Public Health, Los Angeles, California, USA (C.A. Mikosz, M. Kim, C. Tyson, and L. Mascola); New York City Department of Health and Mental Hygiene, New York City, New York, USA (E.H. Lee); New York State Department of Health, Albany, New York, USA (E. Adams);Louisiana Office of Public Health, New Orleans, Louisiana, USA (S. Straif-Bourgeois); Nevada Division of Public and Behavioral Health, Carson City, Nevada, USA (R. Sowadsky); Indiana State Department of Health, Indianapolis, Indiana, USA (S.Arroyo);Illinois Department of Public Health, Springfield, Illinois, USA (Y. Grant-Greene); Colorado Department of Public Health and Environment, Denver, Colorado, USA (J. Duran); City of El Paso Department of Public Health, El Paso, Texas, USA (Y. Vasquez)
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.
Endophthalmitis is inflammation of the intraocular cavities and is often caused by infection (1). Exogenous endophthalmitis is a complication for ≈2–4 per 10,000 intravitreal injections (2,3) or pars plana vitrectomies (4). Most infections are bacterial; fungal infections are rare (5–7). The clinical course of fungal endophthalmitis is frequently prolonged and is associated with poor outcomes; vision loss is not uncommon (5,8–10). We describe 2 concurrent multistate outbreaks of fungal endophthalmitis associated with intraocular use of contaminated products labeled as sterile from a single compounding pharmacy.
Initial Epidemiologic Investigation
On March 5, 2012, the Healthcare Associated Infections Program of the California Department of Public Health was alerted to a cluster of 9 cases of fungal endophthalmitis, all among patients at the same Los Angeles County ambulatory surgical center who had undergone pars plana vitrectomies during October–December 2011. Two patients had histopathologic evidence of fungal hyphae in intraocular eye specimens; the others had a clinical diagnosis of fungal endophthalmitis. The initial investigation, led by the Los Angeles County Department of Public Health, demonstrated that all 9 patients had been exposed to a single lot of Brilliant Blue G dye (BBG), used to stain epiretinal membranes during vitrectomies. Although BBG is not approved by the Food and Drug Administration (FDA) for human use, it is increasingly being used in certain ocular procedures (P. Dugel, pers. comm.). The BBG implicated in the cases reported here was produced on August 23, 2011, at Franck’s Compounding Lab (Franck’s), a compounding pharmacy in Ocala, Florida, USA, which distributes products throughout the United States.
During the investigation, cases were defined as laboratory-confirmed or suspected fungal endophthalmitis among patients who had undergone vitrectomy at the Los Angeles County ambulatory surgical center during October 2011–January 2012, when the implicated BBG lot was in use. No additional cases were identified. A case–control study was conducted among 42 vitrectomy patients (the 9 case-patients and 33 control participants) at the same ambulatory surgical center (11). Information was obtained with regard to the operating surgeon, patient sex, and preoperative and intraoperative medications commonly used for vitrectomies at the Los Angeles County ambulatory surgical center. The only factor significantly associated with case status was Franck’s BBG (odds ratio ∞, p<0.001). Microbiological testing, conducted at a commercial laboratory, of an unopened BBG vial from the same lot yielded the environmental mold Fusarium. These data collectively turned the investigation focus on Franck’s products.
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