Washington, DC – Late last month, the FDA warned health professionals who treat “wet” age-related macular degeneration (AMD) with repackaged intravitreal injections of the drug bevacuzumab that there have been clusters of serious Stretococcus endophthalmitis infections and blindness.
Genentech packages bevacuzumab as Avastin.
Cases of blindness have been found in and around Miami, Florida, and severe eye infections have been reported in Tennessee. At least 12 people in three clinics developed eye infections, and some of them lost all vision in the infected eye.
Officials with the FDA traced the eye infections to a pharmacy in Hollywood, Florida that was repackaging bevacizumab from sterile, injectable, 100 mg/4 mL single-use preservative-free vials into individual 1-mL single-use syringes. The packages were then distributed to multiple eye clinics.
It is believed the problem started because bevacuzumab is primarily used in treating cancer, but has been found to work well in wet AMD in an off-label basis. Genentech makes a similar drug called ranibizumab (Lucentis) that is approved for AMD, but costs $2000 a dose. Bevacuzamab costs $50 a dose. However, the cancer treatment comes in much larger doses, so it must be repackaged into a smaller dose for AMD.
According to the FDA, “Repackaging sterile drugs without proper aseptic techniques can compromise product sterility, potentially putting patients at risk for microbial infections.” They go on to state that it is important all eye doctors and health care professionals ensure bevacuzumab is obtained from a reputable and reliable source, and that it is properly administered.
AMD is the leading cause of legal blindness in the world. Finding drugs that can combat and slow progression of this incurable disease has been ongoing.
For more information about age-related macular degeneration and treatment options, please find an experienced eye doctor in your area today.