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BioThrax

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BioThrax

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Latex

Administer with caution to patients with a possible history of latex sensitivity because the vial stopper contains dry natural rubber and may cause allergic reactions.

Hypersensitivity Reactions

Before administration, the patient's medical immunization history should be reviewed for possible vaccine sensitivities and/or previous vaccination-related adverse reactions, to determine the existence of any contraindications to immunization. [See CONTRAINDICATIONS section] Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. [See CONTRAINDICATIONS section]

Pregnancy

Pregnancy Category D

Pregnant women should not be vaccinated against anthrax unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. Results of a large observational study that examined the rate of birth defects among 37,140 infants born to U.S. military service women who received anthrax vaccine in pregnancy between 1998 and 2004 showed that birth defects were slightly more common in first trimester-exposed infants (odds ratio = 1.18, 95% confidence interval: 0.997, 1.41) when compared with infants of women vaccinated outside of the first trimester and compared to unvaccinated women.1 While the increased birth defect rates were not statistically significant when compared with infants born to women vaccinated outside of pregnancy, pregnant women should not be vaccinated against anthrax unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus.

The effect of BioThrax (anthrax vaccine adsorbed emergent biosolutions) on embryo-fetal and pre-weaning development was evaluated in a developmental toxicity study using pregnant rabbits. One group of rabbits was administered BioThrax (anthrax vaccine adsorbed emergent biosolutions) twice prior to gestation and during the period of organogenesis (gestation day 7). A second group of rabbits was administered BioThrax (anthrax vaccine adsorbed emergent biosolutions) twice prior to gestation and on gestation day 17. BioThrax (anthrax vaccine adsorbed emergent biosolutions) was administered at 0.5 ml/rabbit/occasion, by intramuscular injection. No adverse effects on mating, fertility, pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study.

BioThrax (anthrax vaccine adsorbed emergent biosolutions) can cause fetal harm when administered to a pregnant woman. If this vaccine is used during pregnancy, or if the patient becomes pregnant during the immunization series, the patient should be apprised of the potential hazard to a fetus.

History of Anthrax Disease

History of anthrax disease may increase the potential for severe local adverse reactions.

Altered Immunocompetence

If BioThrax (anthrax vaccine adsorbed emergent biosolutions) is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.

Limitations of Vaccine Effectiveness

Vaccination with BioThrax (anthrax vaccine adsorbed emergent biosolutions) may not protect all individuals. The extent to which one is protected prior to completion of the full immunization schedule is unknown.

Nonclinical Toxicology

BioThrax (anthrax vaccine adsorbed emergent biosolutions) has not been evaluated in non-clinical toxicology studies.

Use In Specific Populations

Pregnancy and Fertility

Pregnancy: Category D. See WARNINGS AND PRECAUTIONS section

Male Fertility: A retrospective study was performed at an in-vitro fertilization clinic to evaluate whether BioThrax (anthrax vaccine adsorbed emergent biosolutions) may impact reproductive function in men. This study compared semen parameters, embryo quality, and pregnancy outcomes in 254 male clients who stated that they had received BioThrax (anthrax vaccine adsorbed emergent biosolutions) , with those of 791 male clients who did not.2 Prior receipt of BioThrax (anthrax vaccine adsorbed emergent biosolutions) did not influence semen parameters (including concentration, motility and morphology), fertilization rate, embryo quality or clinical pregnancy rates.

Nursing Mothers

It is not known whether BioThrax (anthrax vaccine adsorbed emergent biosolutions) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BioThrax (anthrax vaccine adsorbed emergent biosolutions) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established for BioThrax (anthrax vaccine adsorbed emergent biosolutions) .

Geriatric Use

Clinical studies of BioThrax (anthrax vaccine adsorbed emergent biosolutions) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from subjects in the adult population under age 65. Subgroup analysis of study subjects < 30 years, 30 to < 40 years, 40 to < 50 years and > 50 years indicated that subjects in the > 50 years category had statistically insignificant but numerically lower immune responses than younger subjects.

REFERENCES

2. Catherino, W., et al., 2005. The anthrax vaccine does not affect semen parameters, embryo quality, or pregnancy outcome in couples with a vaccinated male military service member. Fertility and Sterility, 83:480-483

Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

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