At least 16 people in Florida and Tennessee have suffered serious eye infections, and some were blinded, after being injected with Avastin. And regulators and the manufacturer say the injuries underscore the risks associated with the unapproved use of the drug, which some doctors reach for when treating the wet form of age-related macular degeneration.

The FDA yesterday issued an alert at least 12 patients who were treated at three clinics in Miami developed infections. While all had some impaired eyesight in the first place, some lost all remaining vision in the treated eye due to endophthalmitis. The episode was traced to a single lot of Avastin that was repackaged and distributed by a pharmacy in Hollywood, Flordia (read the statement).

And in Tennessee, four patients who were injected with Avastin that was contaminated by bacteria, according to The Tennessean. The doses were administered by a hospital in Nashville that is run by the US Department of Veterans Affairs.

The episodes are certain to fuel what is already a raging debate over the unapproved use of Avastin, which is sold by the Genentech unit of Roche. Many ophthalmologists use Avastin to treat wet AMD, which is a common cause of vision loss in the elderly, because it is much cheaper than an alternative. This other med is Lucentis, which is approved to treat the malady and is also sold by Genentech. Dividing a vial of Avastin can wind up costing $50 per injection, compared with $2,000 for Lucentis.

The practice has saved considerable sums of money. One study found that using Avastin saved Medicare some $500 million and prompted a US Senate committee to investigate a rebate program that Genentech once offered physicians to use Lucentis (read this). Off-label use, however, has sparked previous warnings. Three years ago, for instance, Genentech issued a letter to healthcare professional to report 36 cases of off-label use in Canada resulted in adverse events, 32 of which were serious (look here).

The controversy prompted the National Institutes of Health to sponsor a comparative study and the preliminary results released last spring indicated that Avastin is about as effective as Lucentis in treating the wet form of AMD (here is the abstract). The outcome prompted Genentech to quickly lobby Capitol Hill to tout the results of its own separate study that reviewed 78,000 Medicare recipients with AMD showing those given Avastin had an 11 percent higher risk of dying (back story).

Serious injuries are now prompting lawsuits. One of the VA patients in Tennessee, Lloyd Mason Sylvis, 77, suffered an eye infection that spread to his brain, according to a claim for $4 million in damages that his family has filed with the VA, The New York Times reports. “He’s permanently blinded, permanently brain damaged,” his son tells the paper. “He came in walking and talking, and he remains in a vegetative state as we speak.”

The Florida patients received their injections last month and were apparently infected with endophthalmitis. Last week, the FDA announced a recall of syringes containing Avastin from Chroniscript, a unit of Walgreens, in Miami. A Walgreens spokesman tells the Times the syringes were supplied to “a limited number of physician offices in Miami-Dade and Broward counties.”

Meanwhile, Antonio Salgado, a 79-year-old Miami resident had Avastin injected into his right eye last month. There were no problems with seven previous injections, but this one caused severe pain and a white film to grow over his eye, the paper writes. “There was a point in time where his eye was completely white, without coloration, no pupil, no nothing,” his lawyer, Philip Gold, tells the paper.

Another lawyer, Gary Alan Friedman, tells the Times that he represents six patients, four of whom have already filed lawsuits. “They all have either significantly lost vision or have been blinded completely by the contamination,” he says.

Genentech would not comment on the lawsuits, but maintains caution against unapproved use was always advised. “Avastin is not manufactured or approved and to date has not been proven safe for use in the eye,” a spokesman tells the paper. Genentech is also being sued, but as the Times points out, the incidents could provide a benefit if off-label Avastin use is discouraged, raising Lucentis sales.

Meanwhile, Philip Rosenfeld, a retina specialist at the University of Miami who the Times notes had pioneered the use of Avastin for wet AMD, argues the incidents are due to carelessness and should not be seen as a sign that the drug is ineffective. “It took six years for something like this to happen,” he tells the Times, noting that some 2 million eye injections occurred in the US since 2005.