Avastin Injections for Macular Degeneration Treatment Examined in Media Articles
Sterile preparation of the medication may be at issue
September 1, 2011
An article in the New York Times (Avastin Injections Are Reported to Cause Blindness,” August 31, 2011) and other media outlets reported that 16 people in Florida and Tennessee have gotten severe eye infections, and some have been blinded, from injections of the drug Avastin® for treatment for wet age-related macular degeneration (AMD). Some experts are noting that this may be an issue of third-party preparation of the drug and not a side effect of the drug itself.
It was recently reported halfway through the Comparisons of Age-Related Macular Degeneration Treatments (CAAT) trials that Avastin, a drug used off label without U.S. Food and Drug Administration (FDA) approval for treatment of wet AMD, and Lucentis®, an FDA-approved drug for wet AMD, are essentially equivalent in effectiveness (see news update). There are other AMD drugs that are injected into the eye (read information about common treatments). Another drug candidate called Eylea is pending FDA approval.
In general, doctors are not prohibited from prescribing FDA-approved drugs “off label.” This means that the medication was approved for another indication—in this case the FDA approved Avastin as a cancer drug. Since Avastin is only available for sale in large doses for use in cancer treatments, the drug needs to be divided, under sterile conditions, into smaller portions for eye injections to treat wet AMD. It appears that the risk of infection may be very low—these reported side effects were apparently traced to one lot of Avastin at one pharmacy in Hollywood, Florida, according to the FDA. In the Times article, Dr. Philip Rosenfeld, a retina specialist at the University of Miami, emphasized that more than two million eye injections of Avastin have been completed in the United States alone since the practice began in 2005.
“The long-term safety reviews for use of Avastin in eye care are ongoing,” said Guy Eakin, Ph.D., Vice President of Scientific Affairs at the BrightFocus Foundation. “That said, the most common treatments for AMD all involve injections of drugs into the eye. Anyone receiving injections should talk to their physician about the risks of infection, as well as the risks of serious falls or other risks associated with untreated vision loss."
“It's important to be proactive in your own healthcare,” Eakin continued. After receiving any injection into the eye, patients should report increased eye pain, redness, or blurry vision to their eye doctors. “If you do have an infection, early treatment could prevent serious damage from an infection or other complications,” he said.
View all news updates for macular degeneration
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