A single compounding pharmacy is responsible for two simultaneous outbreaks of fungal endophthalmitis caused by contamination with Fusarium mold in “sterile” Brilliant Blue G dye (BBG) made by Franck’s Compounding Pharmacy located in Ocala, Florida. Nine cases of fungal endophthalmitis were initially reported from the contaminated BBG. When the Center for Disease Control (CDC) investigated these fungal infections, it also found that another Franck product, triamcinolone acetonide for intravitreal injection, was contaminated with Fusarium mold, bringing the total of cases to 47 in 9 states. A second fungus, Bipolaris mold, was also found in the products. The rarity of these infections in these outbreaks provided the clue to prompt an investigation by health authorities.
Exposure to either product was sufficient to cause infection and a number of patients received both contaminated products. Vision loss, eye pain and/or floaters were reported by affected patients. Despite antifungal treatment, 14% did not have resolution of the Fusarium infection. Forty two percent (42%) of those infected with Bipolaris mold had ongoing infection and 2 patients ultimately underwent enucleation of the eye. Compounding is primarily regulated at the state level. These 2 concurrent outbreaks of fungal endophthalmitis were neither the first outbreaks linked to contaminated compounded products nor the first investigation of Franck’s for improper compounding practices.
When defective medical products and drugs are put on the market, the injuries to patients are wide spread and devastating. Examples of adulterated drugs from overseas, improperly harvested cadaver grafts and contaminated specialty pharmacy formulations pose dangers to the public. Only careful evaluation of the product and the medical records can tell if you have had a potentially harmful exposure.