US alerts against repackaged injections
Washington, September 6, 2011
The US Food and Drug Administration (FDA) has alerted health care professionals that repackaged intravitreal injections of Avastin (bevacizumab) have caused a cluster of serious eye infections in the Miami, Florida.
The Florida Department of Health (DOH) notified 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, 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 for use in treating patients.
To date, FDA is aware of at least twelve patients in at least three of these clinics who had eye infection, a stateemnt said.
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 statement said.
Health care professionals should be aware that repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections, it added.
Meanwhile, five patients being treated for eye disease were blinded after being injected with Roche Holding’s Avastin at the Los Angeles Veterans Affairs (VA) medical center, according to the New York Times.
VA officials did not respond to requests for comment.
Avastin is a cancer drug, but is commonly used to treat the wet form of age-related macular degeneration and other eye diseases because it costs only about $50 an injection, compared with some $2,000 for Roche's Lucentis, which is approved for treatment of eye diseases.
The company has argued for years the process of dividing up doses creates the risk of contamination.
The tainted Florida injections were traced 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. In the Los Angeles cases, no contaminant has yet been identified, the Times reported.
"Health care professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered," FDA said. – TradeArabia News Service