Eye Problems From Repackaged Bevacizumab

Disclosures

August 31, 2011

August 31, 2011 — The US Food and Drug Administration (FDA) today warned clinicians who treat neovascular or "wet" age-related macular degeneration (AMD) with bevacizumab (Avastin, Genentech) that repackaged intravitreal injections of the drug have caused a cluster of serious Streptococcus endophthalmitis infections and blindness in Miami, Florida.

Cases of severe eye infections caused by bevacizumab also have surfaced in Tennessee.

In the Florida cases, the FDA stated that investigators traced the infections to a pharmacy in Hollywood, Florida, that repackaged bevacizumab from sterile, injectable, 100 mg/4 mL single-use preservative-free vials into individual 1-mL single-use syringes. The pharmacy had distributed the repackaged drug to a number of eye clinics.

The FDA stated that it knows of at least 12 patients in at least 3 clinics who contracted eye infections. Some of them lost all remaining vision in the infected eye.

"While the investigation is not yet complete, the common link for the infections is the pharmacy that repackaged the Avastin and the single lot of Avastin used in the re-packaging," the agency said in a press release.

Bevacizumab is approved for various forms of cancer, but physicians also have prescribed it on an off-label basis for wet AMD, which is the leading cause of legal blindness, because the drug blocks blood vessel growth. Genentech makes a similar drug called ranibizumab (Lucentis) that is approved for wet AMD, but clinicians typically resort to bevacizumab instead because it costs $50 per dose compared with $2000 for a dose of ranibizumab.

A study published in the New England Journal of Medicine earlier this year concluded that bevacizumab works just as well as ranibizumab in treating wet AMD.

However, converting bevacizumab from a cancer drug to an AMD drug means repackaging it into much smaller doses, and that is a problematic process, according to the FDA.

"Repackaging sterile drugs without proper aseptic techniques can compromise product sterility, potentially putting patients at risk for microbial infections," the agency stated. "Healthcare professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered."

Earlier this month, the newspaper The Tennessean reported that 4 patients with wet AMD who were treated with bevacizumab at a Veterans Affairs hospital in Nashville, Tennessee, contracted bacterial infections that led to blindness in at least 1 case. The infections were traced backed to a hospital pharmacy that had repackaged the drugs.

More information about today's FDA announcement is available on the agency's Web site.

To report adverse events related to bevacizumab, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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