Repackaged Avastin causes eye infections in Florida

September 9, 2011

FDA is alerting healthcare professionals that repackaged intravitreal injections of Roche Holdings' Avastin (bevacizumab) have caused a cluster of serious eye infections in the Miami, Fla., area.

FDA is alerting healthcare professionals that repackaged intravitreal injections of Roche Holdings’ Avastin (bevacizumab) have caused a cluster of serious eye infections in the Miami, Fla., area.

The Florida Department of Health notified FDA of a cluster of streptococcal endophthalmitis infections in 3 clinics following intravitreal injection of repackaged Avastin. Investigators traced the tainted injections to a single pharmacy located in Hollywood, Fla. The pharmacy repackaged the Avastin from sterile injectable 100-mg/4-mL, single-use, preservative-free vials into individual 1-mL, single-use syringes.

The pharmacy then distributed the Avastin to a number of eye clinics for use in patient treatment. To date, FDA is aware of at least 12 patients in at least 3 of these clinics who had eye infection. While all these patients had visual deficits before their injections with Avastin, some of these patients lost all remaining vision in the affected eye as a result of the endophthalmitis.

The agency and Florida health officials continue to investigate the cause of the infection. 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 repackaging.

Healthcare professionals should be aware that repackaging sterile drugs without proper aseptic technique can compromise product sterility, putting the patient at risk for microbial infections. Healthcare professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered.

Avastin solution for intravenous infusion is approved for the treatment of various types of cancers. Some physicians also prescribe Avastin off-label for the treatment of wet age-related macular degeneration, although Avastin is not currently approved for this indication. Roche’s Lucentis (ranibizumab injection) has been approved by FDA for wet age-related macular degeneration.

According to The Wall Street Journal online, FDA's warning has the potential to boost Lucentis sales if doctors now using Avastin switch to Lucentis.

Healthcare professionals and patients are encouraged to report any adverse events, side effects, or product quality problems related to the use of repackaged intravitreal injections of Avastin to FDA’s MedWatch Safety Information and Adverse Event Reporting program:

  • Complete and submit the report online: Medwatch Online Voluntary Reporting Form
  • Download form or call (800)-332-1088 to request a reporting form, then complete and return to the address on the preaddressed form, or submit by fax to (800)-FDA-0178.