FFB Written Articles » Macular Degeneration
Infections Caused by Repackaged Avastin Prompt an FDA Alert
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Sept. 8, 2011 - Tainted doses of Avastin, a cancer drug often used off-label to treat wet age-related macular degeneration (AMD), have been traced to a single compounding pharmacy in Hollywood, Florida, according to the U.S. Food and Drug Administration, which issued a nationwide alert last week. 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, resulting, in some cases, 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 the pharmacy. 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. The FDA, which is conducting an investigation, warns pharmacies nationwide that “repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections.”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. Although Avastin has been used, without incident, for several years, The New York Times reported last week that at least nine other patients in two separate locations – Veterans Affairs hospitals in Los Angeles, California, and Nashville, Tennessee – have experienced similar complications. A contaminant was found in Nashville, but not in Los Angeles, and investigations are ongoing, according to the article. For those wet AMD patients who have questions about using either Avastin or Lucentis, the Foundation recommends they speak to their doctors about the best course of treatment. |
