The FDA has come down hard on a compounding pharmacy that repackaged Roche's ($RHHBY) cancer drug Avastin for ophthalmic use. With serious eye infections reported in 5 patients injected with the drug, Clinical Specialties is recalling dozens of lots of the Avastin syringes.
And now that FDA has had time to probe the situation, it's worried about potential contamination of other Clinical Specialties drugs. So, the compounding pharmacy is recalling all of its repackaged sterile products, which amounts to more than 50 drugs.
The cluster of infections in Avastin patients centers on one ophthalmologist's office, FDA says. The doctor was using the Roche drug, repackaged in small doses for use in the eye, to treat patients with macular degeneration. Five serious infections cropped up, and Clinical Specialties pulled 40 lots.
Repackaged Avastin has triggered eye infections before, and some patients actually lost their vision. One cluster of 5 infections was reported at a Veterans Affairs facility in Los Angeles; another group of four arose in a Nashville VA hospital; and another cluster of 12 cropped up in Miami.
Roche has been warning of the risks of this off-label Avastin use for years, but doctors have used it anyway because it's much cheaper than Roche's similar-yet-different eye drug Lucentis. Avastin is expensive at the high doses used for cancer treatment, but the repackaged eye injections cost only about $50 each. Lucentis can run as much as $2,000 per injection.
FDA says it learned about the infections from the Centers for Disease Control and Prevention. Clinical Specialties had distributed the Avastin syringes to doctors' offices in four states. The pharmacy has since notified those doctors by phone, the agency said.
After the agency dug into the case a bit, it announced the larger recall, saying that "practices at the site ... cannot assure the sterility of the products." Aside from the tainted Avastin, there's no evidence that Clinical Specialties products were contaminated.
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