Posted from: Monday, December 28, 2015 - 10:58 AM - Present

Additional Indication Approved for Anthrax Vaccine

November 23, 2015 – The U.S. Food and Drug Administration (FDA) approved a new indication for BioThrax (anthrax vaccine adsorbed) manufactured by Emergent BioSolutions. BioThrax was previously approved to prevent anthrax before exposure for individuals aged 18 years to 64 years old, and is now indicated for patients in the same age range who have already been or suspect they have been exposed to anthrax. It is injected subcutaneously in three doses – one dose is injected immediately after exposure or suspected exposure, a second dose is injected two weeks later, and the third is injected four weeks after exposure. When taking BioThrax, patients should also take an effective antibiotic, such as ciprofloxacin or doxycycline, along with one or more other antibiotics, for at least 60 days. Although the safety of post-exposure BioThrax was confirmed on healthy individuals in human clinical trials, its effectiveness for preventing anthrax after exposure was tested only in laboratory animals because deliberately exposing humans to anthrax is unethical. Between 70% and 100% of treated test animals survived anthrax exposure. BioThrax is the first vaccine to be approved based only on data from animal studies. 

 

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.

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. All trademarks are the property of their respective owners.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Wednesday, July 26, 2017 - 10:49 PM.