F.D.A. Alerts Health Care Professionals of Infection Risk from Repackaged Avastin Intravitreal Injections

On August 30, 2011, the U.S. Food and Drug Administration (F.D.A.) issued a warning to health care professionals regarding use of repackaged Avastin (bevacizumab) in eye injection treatments. The F.D.A. cited 12 recent cases of serious eye infections in the Miami area after use of Avastin for treatment of eye diseases. The Miami patients suffered Streptococcus endophthalmitis infections after receiving Avastin injections from repackaged doses of the drug. All doses came from the same pharmacy that repackaged a single lot of the drug and distributed Avastin single-use syringes to clinics in the Miami area. Due to the endophthalmitis infection, some of the patients lost all sight in the eye that received the Avastin treatment.

The F.D.A. warns health care professionals to ensure product sterility during the repackaging process, as a lack of sterility can increase the risk of microbial infections. Avastin was approved for the treatment of cancer, and has not been approved for the treatment of eye diseases, such as macular degeneration. The F.D.A. has approved Lucentis (ranibizumab) for the treatment of macular degeneration.

See the F.D.A. alert at:

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