Pharmacy Repackaged Avastin Intravitreal Injections Causing Blindess

Washington, DC: The US Food and Drug Administration (FDA) has issued an alert regarding repackaged intravitreal injections of Avastin (bevacizumab) that have caused a cluster of serious eye infections in the Miami, Florida area.

The Florida Department of Health (DOH) notified FDA of a cluster of Streptococcus endophthalmitis infections in three clinics following intravitreal injection of repackaged Avastin. Investigators traced the tainted injections to a single pharmacy located in Hollywood, Florida. The pharmacy repackaged the Avastin from sterile injectable 100 mg/4 mL, single-use, preservative-free vials into individual 1 mL single-use syringes.

The pharmacy then distributed the Avastin to multiple eye clinics for use in treating patients. To date, FDA is aware of at least 12 patients in at least three of these clinics who had eye infection. While all of these patients had visual deficits prior to their injections with Avastin, some of these patients lost all remaining vision in that eye due to the endophthalmitis.

The agency and Florida health officials continue to investigate the cause of the infection. While the investigation is not yet complete, the common link for the infections is the pharmacy that repackaged the Avastin and the single lot of Avastin used in the re-packaging.

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Last updated on Aug-31-11

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