5 More Patients Blinded by Avastin

Sep 2, 2011 11:14am

Five Los Angeles patients receiving Avastin to treat  eye disease have been blinded, the New York Times reported.

The report came after an alert issued by the U.S. Food and Drug Administration Tuesday that 12 patients in the Miami area had suffered eye infections, some leading to blindness, after Avastin injections.

Avastin, made by Genentech, blocks the growth of new blood vessels. Developed and FDA-approved as a cancer drug, Avastin has increasingly been used, outside its approved indication, as a cheap treatment for wet macular degeneration — an eye disease caused by abnormal blood vessel growth. The drug is injected directly into the eye.

The approved treatment for macular degeneration, another Genentech drug called Lucentis, costs about $2,000 per injection compared to Avastin’s $50 price tag. The drugs have the same mode of action. But because Avastin is sold in doses designed for intravenous chemotherapy, doctors are forced to divide it into smaller eye-appropriate doses — a practice that opens the door for  bacterial contamination.

“Health care professionals should be aware that repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections,” the FDA warned Tuesday. ”Health care professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered.”

The 12 Florida eye infection cases were traced back to a single pharmacy in Hollywood, Fla., the FDA reported. The pharmacy repackaged each 4 millimeter vial of Avastin into four 1 millimeter single dose syringes distributed throughout the region.

A contamination source has yet to been identified in the Los Angeles cases, according to the Times.

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