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Academy and FDA Warn Ophthalmologists Regarding Use of Brilliant Blue G for Eye Surgery

The Academy is assisting the U.S. Food and Drug Administration, the U.S. Centers for Disease Control and Prevention and state and local health agencies with an ongoing public health investigation. The FDA has received reports of fungal endophthalmitis in patients who were given Brilliant Blue G (BBG) during eye surgeries. Clinicians in several states have reported adverse events. The BBG was supplied by Franck's Compounding Lab in Ocala, Fla. The pharmacy issued a recall of all lots of BBG on March 9.

Brilliant Blue G is not an approved drug in the United States. The FDA recommends that all Brilliant Blue G be immediately quarantined and returned. This includes all lots of BBG received from Franck's Pharmacy. To assist with this investigation, Academy members are asked to report any cases of post-procedural fungal or bacterial endophthalmitis that occurred in the last six months that are associated with eye surgery in which BBG was used. Reports should be made to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Online at www.fda.gov/MedWatch/report.htm; or
  • Call 800.332.1088 to request a reporting form and return to the address on the pre-addressed form, or submit by fax to 800.332.0178.

For more information, contact the Academy's Governmental Affairs Office at 202.737.6662.

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