Use of Avastin off-label to treat macular degeneration just got a black eye. The FDA is warning that the Genentech cancer drug, when repackaged for eye use, has caused a "cluster of serious eye infections," including some that left patients blind. The tainted Avastin was traced to a single Hollywood, FL, pharmacy that had repackaged Avastin from 4-ml single-use vials into 1-ml syringes.
Meanwhile, the New York Times reports that another, smaller cluster of infections cropped up in Tennessee. The Avastin doses in question here were prepared in the pharmacy of a Veterans Affairs hospital in Nashville. One of those patients has claimed $4 million in damages from the VA; his family says the strep infection spread and caused blindness and brain damage.
The incidents bolster Genentech's contention that repackaged Avastin can be risky. The company, now Roche's U.S. unit, has another drug, Lucentis, developed specifically for wet age-related macular degeneration. But because Lucentis is many times more expensive--and not enormously more effective at AMD relief than Avastin--some eye doctors have turned to the cancer drug instead. The difference is substantial, cost-wise. Avastin injections cost $50 each, while Lucentis runs $2,000, the NYT notes.
Genentech has moved in the past to restrict distribution of Avastin to avoid the pharmacies that repackage the drug for eye use, but angry ophthalmologists persuaded the company to back off partway. However, the company may now have the ammo it needs to really tighten up. "Avastin is not manufactured or approved and to date has not been proven safe for use in the eye," a Genentech spokesman told the Times.
- see the FDA release
- get more from the NYT