Avastin Injections Are Reported to Cause Blindness

At least 16 people in two states have gotten severe eye infections, and some have been blinded, from injections of the drug Avastin, according to health authorities and to lawyers representing the patients.

The incidents, in Florida and Tennessee, demonstrate the risks associated with the money-saving practice of injecting Avastin into the eye to treat the wet form of age-related macular degeneration, a common cause of severe vision loss in the elderly.

Avastin, sold by Genentech, is approved to treat cancer, not eye disease. But many retina specialists use Avastin off label because it costs only about $50 an injection, compared with $2,000 for Lucentis, another Genentech drug that has the same mode of action and is approved as an eye treatment.

The off-label use of Avastin has saved Medicare and patients hundreds of millions of dollars a year. But dividing a vial of Avastin into numerous tiny doses for injection into the eye introduces the risk of bacterial contamination. That is apparently what has happened in the cases in Florida and Tennessee.

The Food and Drug Administration issued an alert late Tuesday saying that at least 12 patients in Miami, treated at three clinics, had suffered eye inflammations. While all had impaired eyesight to begin with, some lost all remaining vision in the treated eye, the agency said.

Avastin is approved for:

Metastatic colorectal cancer (mCRC) when started with the first or second intravenous 5-FU–based chemotherapy for metastatic cancer
Advanced nonsquamous non–small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel in people who have not received chemotherapy for their advanced disease
Metastatic kidney cancer (mRCC) when used with interferon alfa
Glioblastoma (GBM) in adult patients whose cancer has progressed after prior treatment. The effectiveness of Avastin in GBM is based on tumor response. Currently, no data have shown whether or not Avastin improves disease-related symptoms or survival in people previously treated for GBM

The F.D.A. said all the infections involved a single lot of Avastin and had been traced to a single pharmacy in Hollywood, Fla., that had repackaged the drug for use in the eye.

In Tennessee, four patients received shots contaminated by bacteria, according to a statement provided to The Tennessean newspaper by the Tennessee Valley Healthcare System, part of the United States Department of Veterans Affairs. The Avastin doses were prepared in the pharmacy of the V.A. hospital in Nashville.

One of the patients, Lloyd Mason Sylvis, 77, suffered an eye infection of Streptococcus viridans that spread to his brain, according to a claim for $4 million in damages that his family has filed with the V.A. Mr. Sylvis received the injection on March 29, but his family went public with its complaint only recently.