Inhalation Anthrax Treatment Approved
March 25, 2015 – The U.S. Food and Drug Administration (FDA) approved Anthrasil (anthrax immune globulin intravenous [human]). Anthrasil is manufactured by Cangene Corporation and is used to treat patients with symptoms of inhalation anthrax, as well as to individuals who have been exposed, but who have not shown signs of the disease. Anthrasil is administered intravenously (IV) in combination with other antibiotics.
Inhalation anthrax is a rare yet severe form of the disease that is caused by breathing spores from B. anthracis bacteria. Anthrasil, also called AIGIV, is made from blood plasma from healthy individuals who have been vaccinated against anthrax. Now a part of Emergent BioSolutions, Anthrasil has been included in the U.S. Strategic National Stockpile since 2011. The Strategic National Stockpile is maintained by the Centers for Disease Control and Prevention (CDC) and is a secure storage of medicines and supplies that may be needed if a widespread public health emergency threatens availability of essential medicines. Dosing recommendations for Anthrasil are not yet available; however, current therapy regimens, such as a combination of ciprofloxacin with penicillin or doxycycline, usually last for at least two months after exposure because infection can be delayed that long.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.