The cancer drug <"http://www.yourlawyer.com/topics/overview/Avastin-Side-Effects-Lawyers-Lawsuit-Attorney">Avastin has caused a cluster of serious eye infections in the Miami, Florida area, according to the U.S. Food & Drug Administration (FDA). According to a warning to healthcare professionals issued yesterday, a pharmacy had repacked the Avastin from sterile injectable 100 mg/4 mL, single-use, preservative-free vials into individual 1 mL single-use syringes. The drug was then injected into the eyes of patients with wet age-related macular degeneration, an off-label use of the drug.
According to a report from Star News Online, a total of 16 people in Florida and Tennessee have sustained eye infections from this type of Avastin treatment. Some of the infections have resulted in blindness.
Though Avastin has not been approved by the FDA as a treatment for wet age-related macular degeneration, doctors use it this way because it is much cheaper than Lucentis. Lucentis and Avastin are both made by Genentech, and work in a similar fashion. However, according to Star News Online, Avastin costs only about $50 an injection, compared with $2,000 for Lucentis. But using Avastin in this way requires that a vial be divided into numerous tiny doses for injection into the eye, which increases the risk of bacterial contamination.
According to the FDA, 12 people in Florida sustained eye infections in this way. Some lost their remaining vision in the treated eye. Investigators traced the tainted injections to a single pharmacy located in Hollywood, Florida, which distributed the smaller vials to multiple eye clinics. The Florida patients received their injections in early July and were apparently infected with Streptococcus oralis. While its investigation is still ongoing, the FDA says the common link for the infections is the pharmacy that repackaged the Avastin and the single lot of Avastin used in the re-packaging.
According to the Star News Online report, the other four patients were treated by the Tennessee Valley Healthcare System, part of the United States Department of Veterans Affairs. The bacteria-tainted Avastin shots they received were prepared in the pharmacy of the V.A. hospital in Nashville. One patient, a 77-year-old man, suffered an eye infection of Streptococcus viridans that spread to his brain. According to a lawsuit filed by the man’s family, he sustained permanent brain damage and is blind because of the infection, and remains in a vegetative state.
Several other victims of the Avastin eye infections have filed similar lawsuits.
According to the FDA’s alert, 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. Health care professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered, the agency said.