Medication Monitor



Generic Name (Trade Name—Company)
Notes
August 31, 2011

Bevacizumab

(Avastin—Genentech)
Contamination possible with repackaged intravitreal injections

FDA is alerting health providers that repackaged intravitreal injections of bevacizumab have caused a cluster of serious eye infections in the Miami area. The Florida Department of Health notified FDA of Streptococcus endophthalmitis infections in 3 clinics following intravitreal injection of repackaged bevacizumab. FDA is currently aware of at least 12 patients from at least 3 clinics who had an eye infection, with some patients losing all remaining vision in the infected eye as a result of the endophthalmitis.

The source of the infection has been traced back to a single pharmacy in Hollywood, FL, that repackaged bevacizumab from sterile injectable 100 mg/4 mL, single-use, preservative-free vials into individual 1 mL single-use syringes and then distributed these syringes to multiple eye clinics.

FDA is reminding health providers that repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting patients at risk for microbial infections. In addition, health providers should ensure that all drug products are obtained from appropriate, reliable sources and are properly administered.