Contaminated Repackaged Avastin Causes Severe Eye Infections and Blindness
September 1, 2011
The inevitable was bound to happen. A pharmacy in Hollywood, Florida repackaged Avastin into single-use syringes and in the process contaminated the drug that was then sold to several Miami clinics for the treatment of wet advanced macular degeneration (AMD), causing severe eye damage, including complete vision loss in a few patients.
And in Tennessee, a VA Hospital injected four patients with repackaged, contaminated Avastin.
The FDA has issued an alert warning health care professionals that repackaged intravitreal injections of Avastin (bevacizumab) have caused a cluster of serious eye infections in the Miami, Florida area.
The risk of contaminated Avastin arises because while Avastin is approved for treating various forms of cancer, it is not approved for treating wet AMD. Yet, many ophthalmologists use it off-label to treat wet AMD because it costs so much less than Lucentis. The issue is that converting Avastin from a cancer drug to a wet AMD drug means repackaging it into much smaller doses. If that repackagaging process is not handled with proper aseptic techniques, product sterility can be compromised, which puts patients at risk for microbial infections.
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