Food and Drug Administration issues alert in Miami

Aug 31, 2011

The following article was published in PropertyCasualty360º on August 31, 2011:

FDA issues alert in Miami

The U.S. Food and Drug Administration (FDA) is alerting health care professionals that repackaged intravitreal injections of Avastin (bevacizumab) have caused a cluster of serious eye infections in the Miami area.

The Florida Department of Health notified the FDA of a cluster of Streptococcus endophthalmitis infections in three 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 multiple eye clinics for use in treating patients. 

To date, the FDA is aware of at least 12 patients in at least three of these clinics who had eye infections. While all of these 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.

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.

Avastin is manufactured by Genentech, Inc., headquartered in San Francisco. According to the company’s website, Avastin is the first FDA-approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor. The site states that, “Avastin is approved, in combination with intravenous 5-fluorouracil-based chemotherapy, for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum; in combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; and for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.”

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