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Drugs

FDA Warns Physicians about Using Brilliant Blue G for Eye Surgery


For current information, please see 4/20/2012 Update to this statement.

 

[03-19-2012] FDA has received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG) during eye surgeries.  The BBG was supplied by Franck’s Compounding Lab, Ocala, Florida. Brilliant Blue G is not an approved drug in the United States.

Clinicians in several states reported the adverse events.  FDA, the Centers for Disease Control and Prevention, and local and state public health agencies are actively investigating these incidents.

FDA requests that practitioners report to FDA any cases of suspected fungal endophthalmitis, which have occurred within the last six months, associated with eye surgery using BBG.

Reports should be sent to FDA’s MedWatch Safety Information and Adverse Event Reporting program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Franck’s Compounding Lab issued a recall on March 9, 2012, of all lots of Brilliant Blue G. Franck’s Recall Letter: http://www.fda.gov/Safety/Recalls/ucm296326.htm

 

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