Biothrax Pregnancy Warnings
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
US FDA pregnancy category: D
Comments:
-This vaccine can cause fetal harm when given during pregnancy.
-Apprise pregnant patients or those who become pregnant while on this product of the potential hazard to the fetus.
Animal studies are not available. A large observational study of birth defects in 37,140 infants born to mothers in the US military who had received anthrax vaccine showed birth defects occurring slightly more commonly (odds ratio = 1.18, 95% confidence interval) in women vaccinated outside of the first trimester compared to unvaccinated patients; while the increase was not statistically significant, vaccination during pregnancy should only occur if benefits outweigh the risks. A retrospective study at an in-vitro fertilization clinic found no differences in semen parameters (including concentration, motility, and morphology), fertilization rate, embryo quality, or clinical pregnancy rates between males exposed to anthrax vaccine adsorbed and those not exposed.
Encourage patients who are exposed to this vaccine during pregnancy to inform their healthcare provider and enroll in the BioThrax(R) (Anthrax) Vaccine in Pregnancy Registry (Phone: 1-619-553-9255).
US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
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