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FDA Alert: Infection Risk from Repackaged Avastin Intravitreal Injections
FDA alerts health care providers that repackaged intravitreal injections of Avastin® (bevacizumab) have caused a cluster of serious eye infections in the Miami, FL, area. Avastin is a solution for intravenous infusion that is approved for the treatment of various types of cancers. The Florida Department of Health (DOH) notified FDA of a cluster of Streptococcus endophthalmitis infections in three clinics following intravitreal injection of repackaged Avastin. The tainted injections were traced to a single pharmacy located in Hollywood, FL. The pharmacy repackaged the Avastin from sterile injectable 100 mg/4 mL, single-use, preservative-free vials into individual 1 mL single-use syringes, and distributed the Avastin to multiple eye clinics for use in treating patients, as explained in an FDA Alert.
FDA reports that to date, “the agency is aware of at least twelve 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.” FDA and Florida health officials are continuing the investigation, but FDA notes that “the common link for the infections is the pharmacy that repackaged the Avastin and the single lot of Avastin used in the re-packaging.”
FDA advises health care providers to be aware that repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections. Further, FDA stresses that health care providers should ensure that drug products are obtained from appropriate, reliable sources and are properly administered.
Health care providers and patients are encouraged to report any adverse events, side effects, or product quality problems related with the use of repackaged intravitreal injections of Avastin to the FDA MedWatch Safety Information and Adverse Event Reporting program by completing the online form or by calling 800/332-1088 to request a printed form.
