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New York Times: Contaminated Avastin Causing Blindness

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New York Times: Five veterans in Los Angeles were blinded after receiving Avastin to treat eye disease, prompting an investigation by the Department of Veterans Affairs. To date, at least 21 patients have suffered eye infection or blindness after being injected with Avastin.

In a September 1, 2011 article, the New York Times reported five veterans were blinded after undergoing Avastin eye disease treatment for “wet” macular degeneration at the Los Angeles Veterans Affairs medical center.

All five patients received their injections on August 12, 2011 at the Veterans Affairs Sepulveda Ambulatory Care Center in the San Fernando Valley. However, the patients reportedly learned the drug came from the pharmacy at the Veterans Affairs main campus in Los Angeles.

One patient told the New York Times:

“We all ended up in the E.R. over the course of the next few days and put together the connection.”

In addition, 4 patients at a Nashville Veterans Affairs hospital suffered infection after receiving a bacterially contaminated Avastin treatment. And the FDA has received 12 additional reports of eye infection in patients who received Avastin treatment in Miami, Florida. Some of these patients lost all remaining vision in the treated eye due to the infection, called Streptococcus endophthalmitis.

Avastin, manufactured by Genentech, is FDA approved for treatment of various types of cancers. Doctors also prescribe it for macular degeneration, a condition usually affecting older adults, where damage to the retina causes a loss of vision in the center of the visual field. The “wet” form of this condition is caused when abnormal blood vessels grow behind the retina, causing the vision loss. Avastin treats “wet” macular degeneration by blocking a protein from stimulating new blood vessel growth. Avastin is not FDA approved for this kind of treatment.

However, doctors prescribe the Avastin injections because they cost approximately $50 each. In comparison to the $2,000 FDA-approved Lucentis injections, Avastin is much cheaper and saves patients money.

Approximately 30-40 patients receive eye disease injections per week from Veterans Affairs in Los Angeles. Veterans Affairs has temporarily suspended Avastin injections and replaced them with the more expensive Lucentis injections.

Avastin eye disease dosages are created by dividing up larger doses of the drug. A vial meant for cancer treatment is divided into tiny doses, which are placed into a syringe to be injected into the eye. It could be this extra handling that causes bacterial contamination of the injections, leading to the infection.

The Miami infections were traced back to tainted injections distributed by a pharmacy in Hollywood, Florida. The pharmacy repackaged larger doses of sterilized Avastin injections into individual 1 mL single-use syringes. These syringes were then distributed to multiple eye clinics. To date, the FDA has traced eye infections to at least three of these clinics.

The FDA warns the syringes may not have been properly sterilized, leading to the infections:

“Health care professionals should be aware that repackaging sterile drugs withough proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections. Health care professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered.”

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