Reactions 1368 - 10 Sep 2011

Eye infections linked to intravitrealbevacizumab

The Florida Department of Health has notified the USFDA of a cluster of serious Streptococcusendophthalmitis eye infections occurring in the Miami,Florida area associated with repackaged intravitrealinjections of bevacizumab [Avastin]. The FDA and healthofficials are continuing to investigate the cause of theinfections.

The injections have been traced to a single pharmacywhere a single lot of sterile injectable bevacizumab100 mg/4mL, single-use, preservative-free vials wererepackaged into individual single-use 1mL syringes, thendistributed to multiple eye clinics to treat patients. Todate, the FDA is aware of at least 12 cases of eyeinfections occurring in at least three of these clinics. Allof the patients had visual impairment prior to intravitrealbevacizumab injection, but some of these patients lostall remaining vision in the eye due to endophthalmitis.

The FDA advises healthcare professionals thatrepackaging sterile drugs without use of proper aseptictechnique can lead to product contamination and risk ofmicrobial infections in patients. They add thatbevacizumab solution for IV infusion is approved for thetreatment of various types of cancer. Bevacizumab is notcurrently approved for use in wet age-related maculardegeneration, although some physicians do prescribethe drug off-label for this indication.FDA. FDA Alerts Health Care Professionals of Infection Risk from RepackagedAvastin Intravitreal Injections. Internet Document : [1 page], 30 Aug 2011.Available from: URL: http://www.fda.gov 801085449

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Reactions 10 Sep 2011 No. 13680114-9954/10/1368-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved