The U.S. Food and DrugAdministration (FDA) is alerting health care professionals thatrepackaged intravitreal injections of Avastin (bevacizumab)have caused a cluster of serious eye infections in the Miamiarea.

The Florida Department ofHealth notified the FDA of a cluster of Streptococcusendophthalmitis infections in three clinics following intravitrealinjection of repackaged Avastin. Investigators traced thetainted injections to a single pharmacy located in Hollywood,Fla. The pharmacy repackaged the Avastin from sterileinjectable 100 mg/4 mL, single-use, preservative-free vials intoindividual 1 mL single-use syringes. The pharmacy thendistributed the Avastin to multiple eye clinics for use in treatingpatients.

To date, the FDA is aware of at least 12 patients in at leastthree of these clinics who had eye infections. While all of thesepatients had visual deficits prior to their injections withAvastin, some of these patients lost all remaining vision in thateye due to the endophthalmitis.

While the investigation is not yet complete, the common link forthe infections is the pharmacy that repackaged the Avastin and thesingle lot of Avastin used in the re-packaging.

Avastin is manufactured by Genentech, Inc.,headquartered in San Francisco. According to the company's website,Avastin is the first FDA-approved therapy designed to inhibitangiogenesis, the process by which new blood vessels develop andcarry vital nutrients to a tumor. The site states that, “Avastin isapproved, in combination with intravenous 5-fluorouracil-basedchemotherapy, for first- or second-line treatment of patients withmetastatic carcinoma of the colon or rectum; in combination withcarboplatin and paclitaxel for the first-line treatment of patientswith unresectable, locally advanced, recurrent or metastaticnon-squamous non-small cell lung cancer; and for the treatment ofmetastatic renal cell carcinoma in combination with interferonalfa.”