On the Heels of an FDA Alert, Department of Veteran Affairs Bans Avastin
In the latest chapter of an ongoing saga involving Avastin, a cancer drug used off-label to treat wet age-related macular degeneration (AMD), the U.S. Department of Veterans Affairs recently halted use of the drug in its hospitals. A statement issued by the VA in late September advised its physicians to “consider alternate therapies” until an investigation of Avastin is complete. The VA will then reassess the use of Avastin and offer guidance.
Although Avastin had been used, without incident, for several years, The New York Times recently reported that at least nine patients in two VA hospitals – in Los Angeles, California, and Nashville, Tennessee – suffered from serious infections after being injected with Avastin.
The VA’s announcement came three weeks after the U.S. Food and Drug Administration issued a nationwide alert warning that repackaged injections of the drug, all of which came from the same pharmacy, caused serious eye infections in at least 12 patients in three Florida eye clinics. In some cases, the infections resulted in complete blindness, according to news reports.
The alert notes that the Florida Department of Health “notified [the] FDA of a cluster of Streptococcus endophthalmitis infections” in patients who’d been injected using syringes coming from a pharmacy in Hollywood, Florida. Because Avastin is used primarily for cancer patients, it is not packaged for eye treatments. It must, therefore, be removed from a sterile vial and divided into smaller doses – a process known as compounding.
The FDA, which is conducting an investigation of its own, warned pharmacies nationwide that “repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections.”
The American Society of Retinal Specialists (ASRS) has since followed up with recommendations of its own, based on a survey it conducted among member physicians, asking whether they’ve experienced any Avastin-related problems and, if so, what the causes were. The physicians were also asked if they were cognizant of their local compounding pharmacies’ safety standards. Working in conjunction with the International Academy of Compounding Pharmacists and the Pharmacy Compounding Accreditation Board, the ASRS has made the safety information available online to its 2,400-plus members.
Many doctors prescribe Avastin, which blocks the growth of leaky blood vessels that occurs with wet AMD, because each injection costs about $50, compared to $2,000 for Lucentis, an FDA-approved drug for the treatment of wet AMD. Both drugs were developed by the company Genentech, which is owned by Roche.
According to the news agency Reuters, the VA’s announcement boosted share prices of Regeneron Pharmaceuticals, Inc., which is awaiting FDA approval of its own treatment for wet AMD. Called Eylea, the drug, like Lucentis, was designed specifically for eye treatment. Although the FDA has given tacit approval of Eylea, it’s not due to make its final decision until November.
Ironcially, a government-sponsored study concluded, this past April, that Avastin is equally effective as Lucentis in preserving vision in people with wet AMD. Known as the Comparison of Age-Related Macular Degeneration Treatment Trials (CATT), the 1,200-participant multicenter study is the largest comparison to date of the two popular AMD treatments.
Roche has always claimed that Avastin is not appropriate for eye treatments, citing, as the FDA has, potential dangers during the compounding process.