Repackaged Avastin caused eye infections in Florida

CHICAGO Wed Aug 31, 2011 8:49am EDT

CHICAGO Aug 31 (Reuters) - Repackaged injections of the cancer drug Avastin, also known as bevacizumab, have caused a cluster of serious eye infections in the Miami, Florida area, the U.S. Food and Drug Administration said on Wednesday.

The Florida Department of Health notified the FDA of Streptococcus endophthalmitis infections in three clinics following injections given through the eye of repackaged Avastin, manufactured by Roche Holdings (ROG.VX).

Investigators traced the tainted injections to a single pharmacy located in Hollywood, Florida. 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 multiple eye clinics.

The FDA said it is aware of at least 12 patients in at least three of these clinics who had eye infections. While all of the patients had visual deficits prior to their injections with Avastin, some of these patients lost all remaining vision in that eye due to the endophthalmitis.

The agency and Florida health officials continue to investigate. (Reporting by Debra Sherman, editing by Dave Zimmerman)

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