Postprocedural Fungal Endophthalmitis Associated with Sterile Products from a Single Compounding Pharmacy — Multiple States, 2012

Mikosz, Christina

Wednesday, June 12, 2013: 2:00 PM

Ballroom C (Pasadena Convention Center)

Christina Mikosz , Centers for Disease Control and Prevention, Los Angeles, CA

Rachel Smith , Centers for Disease Control and Prevention, Atlanta, GA

Moon Kim , Los Angeles County Department of Public Health, Los Angeles, CA

Clara Tyson , Los Angeles County Department of Public Health, Los Angeles, CA

Kelsey OYong , Los Angeles County Department of Public Health, Los Angeles, CA

Kavita Trivedi , California Department of Public Health, Richmond, CA

Ellen Lee , New York City Department of Health and Mental Hygiene, New York City, NY

Susanne Straif-Bourgeois , Louisiana Office of Public Health, New Orleans, LA

Rick Sowadsky , Nevada State Health Division, Carson City, NV

Benjamin Sun , Centers for Disease Control and Prevention, Carson City, NV

Shannon Millay , Indiana State Department of Health, Indianapolis, IN

Stephanie Black , Chicago Department of Public Health, Chicago, IL

Yoran Grant , Centers for Disease Control and Prevention, Springfield, IL

Judith Conway , Illinois Department of Public Health, Springfield, IL

Wendy Bamberg , Colorado Department of Public Health and Environment, Denver, CO

Yvonne Vasquez , City of El Paso Department of Public Health, El Paso, TX

Julie Harris , Centers for Disease Control and Prevention, Atlanta, GA

Shawn Lockhart , Centers for Disease Control and Prevention, Atlanta, GA

Thomas Torok , Centers for Disease Control and Prevention, Tallahassee, FL

Laurene Mascola , Los Angeles County Department of Public Health, Los Angeles, CA

Benjamin Park , Centers for Disease Control and Prevention, Atlanta, GA

BACKGROUND: Fungal endophthalmitis is a rare but serious infection that can cause vision loss. In March 2012, the California and Los Angeles County Departments of Public Health were notified of nine fungal endophthalmitis cases after retinal surgery at a California ambulatory surgical center. We investigated to identify the source and prevent additional cases.

METHODS: Probable cases were defined as ophthalmologist-diagnosed fungal endophthalmitis after an intraocular procedure performed after August 23, 2011, the production date of a suspected product. Confirmed cases had fungi identified by culture, histopathology, or polymerase chain reaction. Case-finding occurred through Epi-Xposts, FDA MedWatch alerts, e-mails to ClinMicroNet laboratories and two ophthalmologist professional associations, and sales record review. Microbiologic and genetic testing were performed on patient specimens and available suspected product. Patient charts were reviewed.

RESULTS: We identified 43 confirmed and probable cases in nine states; 21 had prior exposure to Brilliant Blue-G (BBG) dye during retinal surgery, and 22 had prior intravitreal injection of triamcinolone acetonide (TAC). Both BBG and TAC were compounded at Pharmacy X. Fusarium incarnatum-equiseti species complex mold was identified in specimens from BBG-exposed case-patients and from unopened Pharmacy X BBG vials. Bipolaris hawaiiensis mold was identified in specimens from TAC-exposed case-patients. Of 40 patients with available data, 39 (98%) suffered vision loss, and 36 (90%) required repeat ophthalmic surgery. CDC advised avoidance of Pharmacy X sterile compounded products, which were recalled on May 21, 2012.

CONCLUSIONS: We describe a multistate outbreak of postprocedural fungal endophthalmitis associated with two compounded products labeled as sterile from a single compounding pharmacy, resulting in widespread Pharmacy X product recall. Clinicians should be aware that contamination of sterile compounded products can occur.