FDA's Avastin rules may not be necessary

August 18, 2015

While FDA is proposing that bevacizumab (Avastin) for macular degeneration be used within 5 days of re-packaging to avoid development of endophthalmitis in patients, that precaution may not be necessary, according to a new study.

While FDA is proposing that bevacizumab (Avastin) for macular degeneration be used within 5 days of re-packaging to avoid development of endophthalmitis in patients, that precaution may not be necessary, according to a new study.

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Researchers conducted the study, published in the August 13 issue of JAMA Ophthalmology, to determine whether the current draft guidelines set forth by FDA for compounded or repackaged medications should be applied to bevacizumab.

The guidelines would “greatly limit the availability and use of bevacizumab by ophthalmologists across the country,” wrote lead author Brian L. VanderBeek, MD, MPH, associate professor of ophthalmology at the University of Pennsylvania’s Perelman School of Medicine. “Little evidence beyond highly publicized case reports exists for or against the need for additional regulation of compounded bevacizumab.”

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Headlines such as “Avastin Injections Are Reported to Cause Blindness,” focused on bevacizumab as the culprit for health problems, and not the compounding process itself, the researchers found. “The first (and to date only) peer-reviewed report to describe compounding-related endophthalmitis was published a few months after the lay press reports and described 12 cases of endophthalmitis in Florida, all linked to a single compounding pharmacy,” the researchers wrote.

The researchers reviewed health insurance claims data for 58,612 patients who received more than 380,000 injections of 2 drugs, Avastin and ranibizumab (Lucentis). The incidence of endophthalmitis in the 2 drugs was similar: .017% in the bevacizumab group and .025% in the  ranibizumab group. “We found no significant association with development of endophthalmitis after a bevacizumab injection compared with ranibizumab,” the researchers wrote.

Meanwhile, FDA’s new proposal would effectively prohibit most opthamologists from using it, VanderBeek told Philly.com. Compounding pharmacies generally need 14 days to test the repackaged product for sterility. "My hope is that the news of this study reaches them [the FDA] prior to a final decision being made," he said.

FDA draft guidelines may actually have the unintended consequence of increasing endophthalmitis rates by shifting use to less-safe office-loaded syringes, the researchers wrote.

The authors also noted that an advantage of the study is that it consisted of individuals from all 50 states. “Given the sizable geographic distribution of the cohort, data from multiple compounding pharmacies likely are represented within this data set. In comparison, large single-center reports are likely to have all their bevacizumab come from a single pharmacy, which only verifies the safety of that specific distribution site,” they wrote.

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