FDA cites preparedness for intentional release of anthrax
WEDNESDAY, March 25, 2015 (HealthDay News) — Anthrasil, Anthrax Immune Globulin Intravenous (Human), has been approved by the U.S. Food and Drug Administration to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.
Anthrasil is sanctioned, when combined with approved antibiotics, to support the nation’s preparedness against a possible anthrax attack, the FDA said Wednesday in a news release. Other rare but possible means of human exposure to the deadly bacteria include infected animals or contaminated animal products.
Anthrasil is made from the plasma of people who have been vaccinated against anthrax. The plasma includes antibodies that neutralize toxins produced by anthrax, the FDA said. The drug will be stored in the U.S. Strategic National Stockpile for use in an “anthrax emergency.”
Because it wasn’t “feasible or ethical” to expose people to anthrax, Anthrasil’s effectiveness was tested in rabbits and monkeys, the agency said. The vaccine’s safety was evaluated among 74 healthy people who weren’t exposed to anthrax. The most common side effects included headache, back pain, nausea, and pain and swelling at the injection site.
Anthrasil is produced by Cangene Corp., based in Winnipeg, Canada.