Pharmaceutical

FDA, CDC warn of illegal, fungus-contaminated eye surgery drug

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are warning eye doctors that a drug used in eye surgeries known as Brilliant Blue G (BBG) is illegal and has caused fungal endophthalmitis, or eye infections, in some patients. Both federal agencies, along with local and state public health agencies, are actively investigating these adverse events.

The BBG was supplied by Franck’s Compounding Lab in Ocala, Florida. The company issued a recall on March 9, 2012, of all lots of Brilliant Blue G and issued a recall letter. The drug is not approved for use in the United States.

BBG is used as a stain to assist surgeons in retinal surgery. It has recently been used in scientific experiments to treat spinal injuries in laboratory rats. Testing is still in progress to determine if this treatment can be used effectively in humans.

The FDA requests that practitioners report any adverse events or side effects related to use of this drug to the agency’s MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm. The drug and side effects have been reported in several states to date.

Franck’s Compounding Lab issued a notice to its customers that the drug was being recalled because of possible fungal contamination, however the company did not reveal that the drug was not approved by the FDA. The company has agreed to issue credit on any of the BBG products returned to it.

Source: FDA