The United States Food & Drug Administration (FDA) has announced an urgent recall of Brilliant Blue G, distributed by Franck’s Compounding Lab in Ocala, Florida. The recall has issued on March 9, 2012. According to the recall notice, Brilliant Blue G has been associated with fungal infections of the eye. According to the pharmacy, lots [email protected], [email protected], [email protected], and [email protected] are suspected of fungal contamination. There have been at least twelve reports of eye infections from products sold specifically from the Florida compounding pharmacy. The same pharmacy had a recall in September of 2011.
Brilliant Blue G, which is used in surgeries in the United States and other countries, is not a FDA approved drug. Brilliant Blue G is a common food additive that gives M&M and Gatorade their blue tint. But in 2009, scientists discovered that Brilliant Blue G had the ability to prevent immediate and secondary effects of spinal cord injuries. More recently, Brilliant Blue G has been used to treat patients during eye surgeries.
Clinicians reported that patients began experiencing fungal and bacterial endophthalmitis after being treated with Brilliant Blue G. Such eye infections can lead to other complications, like photophobia, red eye, and even vision loss. While several other dyes are used during eye surgery, only Brilliant Blue G has been recalled. Patients whose doctors have prescribed this medication should speak to their physician immediately.