Eye Infections, Complications Due to Off-Label Usage of Avastin

September 13, 2011

By Rachelle Matherne

According to an FDA advisory issued August 30, 12 patients have developed serious bacterial infections after using intravitreal injections of bevacizumab (Avastin). Of these 12 patients who developed Streptococcus endophthalmitis, which can lead to blindness and brain damage, at least five have lost all remaining vision in their treated eyes. The incidents occurred in three different clinics in Miami, Los Angeles, and Nashville.

The incidents have been linked to a compounding pharmacy in Hollywood, FL, where pharmaceuticals are mixed to fit specific needs of a patient, such as changing the medication from a pill to a liquid. The pharmacy had repackaged the bevacizumab from sterile 100 mg/4 ml, single-use, preservative-free vials into individual 1-ml single-use syringes. Repackaging sterile drugs without proper aseptic considerations can allow bacterial contamination, potentially leading to microbial infections.

Genentech — now owned by Roche — is the creator of Avastin and has argued for years against repackaging the drug due to the risk of contamination. Avastin, a cancer drug, is not FDA-approved for eye use, although Genentech’s Lucentis (ranibizumab) is. For financial reasons, however, ophthalmologists have prescribed Avastin as a treatment for wet age-related macular degeneration (wet AMD), which affects up to one million patients in the U.S. alone. Avastin costs around $50 per injection compared to $2,000 for Lucentis.

The off-label usage also meant considerable savings for Medicare, the federal health program for the disabled and the elderly. Results of an audit published last week by the Department of Health and Human Services found that Medicare could have saved $1.1 billion in 2008 and 2009 by using Avastin rather than Lucentis, and Medicare beneficiaries could have saved $275 million in co-payments.

Johns Hopkins University published a study earlier this year comparing Avastin and Lucentis eye injections. Researchers found that patients using Avastin were 11% more likely to die and 57% more likely to suffer a stroke. The study was funded by Roche and analyzed 78,000 Medicare patients. Similarly, the federal government also funded a clinical trial to compare the two medications. Avastin proved as effective as Lucentis, but patients using the former were more likely to be hospitalized.

Meanwhile, and unrelated to the cases of Streptococcus endophthalmitis, the FDA has extended its target date to complete its review of a medicine called Eylea from Regneron Pharmaceuticals Inc. If approved, the drug would be used like Lucentis to combat wet AMD, but with less frequent injections.

Rachelle Matherne is a writer for firstSTREET Online, a leading provider of vision solutions for seniors, including lightweight, hands-free magnifiers and magnifying glasses. Rachelle discusses health advice for seniors on the firstSTREET blog.

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