Adverse reactions
There have been no long-term sequelae of the known adverse events (local or systemic reactions) and no pattern of frequently reported serious adverse events for AVA.The approved FDA package insert for AVA contains the following notice: "The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema and arm motion limitation. The most common (>5%) systemic adverse reactions were muscle aches, fatigue and headache." Also, "Serious allergic reactions, including anaphylactic shock, have been observed during post-marketing surveillance in individuals receiving BioThrax". Drug interactions
The approved US FDA package insert for AVA contains the following notice:

Immunosuppressive therapies may diminish the immune response to BioThrax. Post-exposure vaccination
Some studies show that use of antibiotics effective against anthrax plus administration of AVA is the most beneficial approach for purposes of post-exposure prophylaxis. This practice has been endorsed by the Advisory Committee on Immunization Practices (ACIP), the Johns Hopkins Working Group on Civilian Biodefense, and the 2002 Institute of Medicine report on the vaccine. However, AVA is not licensed for post-exposure prophylaxis for inhalational anthrax or for use in a 3-dose regimen. Any such use, therefore, would be on an off-label or IND (officially experimental) basis. "... the safety and efficacy of BioThrax for post-exposure setting have not been established.". Controversy
In the United States
Although many individuals have expressed health concerns after receiving anthrax vaccine, a congressionally directed study by the Institute of Medicine (part of the National Academy of Sciences) concluded that this anthrax vaccine is as safe as other vaccines.
Cystitis cystica is a relatively common chronic reactive inflammatory disorder thought to be caused by chronic irritation of the urothelium because of infection, calculi, outlet obstruction, or tumor resulting in multiple small filling defects in the bladder wall. == References ==