Army veteran Lloyd Sylvis visited the VA hospital in Nashville on March 29 to get a new pair of glasses. He ended up getting a bacteria-tainted shot of Avastin (bevacizumab, Genentech)—and so did four other patients at the facility, according to a lawsuit.
Mr. Sylvis’ family is now suing the U.S. Department of Veterans Affairs for $4 million, claiming that bacteria-tainted bevacizumab resulted in blindness and brain damage. The complaint also claims at least one doctor stated the medication became contaminated while being mixed inside the hospital pharmacy.
The cost-cutting, compounding procedure is common at VA hospitals nationwide. Avastin, used off label, is as effective at treating AMD as FDA-approved Lucentis (ranibizumab, Genentech), but only costs about $50 per dose compared to $2,000 for a single-dose vial of Lucentis.1 The problem is Avastin doesn’t come in single-dose vials for eye injection because it’s not approved for that purpose. This means hospital pharmacies must compound the drug from its original form, which is intended for intravenous use.
The VA released a statement saying, “The patients affected were provided disclosure of the incident. A thorough analysis of the incident was completed to ensure the safety of the patients we treat.” The claim in Nashville is still pending.
Meanwhile, the New York Times reported that five patients with macular degeneration were blinded on August 12 after receiving injections of Avastin at the VA Sepulveda Ambulatory Care Center in California.
No contaminant has yet been identified, the New York Times said, but the drug is believed to have come from the pharmacy at the main campus of the VA Greater Los Angeles Healthcare System in Los Angeles.
On August 30, the FDA issued a warning that at least 12 patients in the Miami area had been infected with Streptococcus endophthalmitis from injections of Avastin. Investigators traced the tainted injections to a single pharmacy located in Hollywood, Fla. The pharmacy had then distributed the Avastin to multiple eye clinics.
“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,” the FDA statement said. “Health care professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered.”
The FDA encourages health care professionals and patients to report any adverse events, side effects or product quality problems related to intravitreal injections of Avastin to the FDA’s MedWatch Safety Information and Adverse Event Reporting program: www.fda.gov/MedWatch/report.htm.
1. CATT Research Group, Martin DF, Maguire MG, et al. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19;364(20):1897-908.
