August 31, 2011
SAFETY ALERT: FDA Warns of Infection Risk with Repackaged Avastin Intraviteal InjectionsThe FDA is alerting healthcare professionals that repackaged intravitreal injections of Avastin (bevacizumab; Genentech) have caused a cluster of serious eye infections in the Miami area. The Florida Department of Health notified the FDA of a cluster of Streptococcus endophthalmitis infections in three clinics following intravitreal injection of repackaged Avastin. Investigators have traced the tainted injections to a single pharmacy located in Hollywood, Florida. The pharmacy repackaged the Avastin from sterile injectable 100mg/4mL, single-use, preservative-free vials into individual 1mL single-use syringes. The FDA and Florida health officials continue to investigate the cause of the infection.
Healthcare professionals should be aware that repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections. Healthcare professionals should ensure that drug products are obtained from appropriate, reliable sources and are properly administered.
Avastin is approved for the treatment of various types of cancers. Some physicians also prescribe Avastin off-label for the treatment of wet age-related macular degeneration, although Avastin is not currently approved for this indication.
For more information visit www.fda.gov/Drugs/DrugSafety/ucm270296.htm.