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    Pregnancy and Breastfeeding Risk Categories: Vaccines

    Smallpox Vaccine

    From Anthrax to Yellow Fever, learn about the safety of the most common vaccines during pregnancy and breastfeeding with the following general overview of vaccines.

    VaccinePregnancy Risk CategoryBreastfeeding Risk Category
    Anthrax VaccineCL3
    Cholera Vaccine
    (Dukoral)
    CL3
    Diphtheria + Tetanus + Pertussis Vaccine
    (DTap/Tdap/DTP)
    BL2
    Diphtheria + Tentanus Vaccine
    (DT, Td, Decavac)
    CL3
    Diphtheria VaccineCL3
    Haemophilus B Conjugate Vaccine
    (HibTITER, Haemophilus B Vaccine, ProHIBiT, OmniHIB, Act-HIB, PedvaxHIB, Hib Titer)
    CL3
    Hepatitis A + Hepatitis B Vaccine
    (Twinrix)
    CL3
    Hepatitis A Vaccine
    (Havrix, Vaqta)
    CL3
    Hepatitis B Vaccine
    (Heptavax-B, Energix-B, Recombivax HB)
    CL2
    Human Papillmoavirus Vaccine
    (Gardasil, Cervarix, HPV Vaccine)
    BL3
    Influenza Virus Vaccines
    (Flu Shot, Influenza Vaccine, Flu-Imune, Fluogen, Fluzone, FluMist, Flu Vaccine)
    CL1
    Japanese Encephalitis Vaccine
    (Ixiaro)
    BL3
    Je-Vax
    (Encephalitis Vaccine)
    XUnknown
    Lyme Disease Vaccine
    (LYMErix)
    CL2
    Measles + Mumps + Rubella Vaccine
    (MMR Vaccine, M-M-R II, ProQuad, Priorix)
    CL2
    Measles + Mumps + Rubella + Varicella Vaccine
    (ProQuad, MMRV Vaccine)
    CL3
    Measle Virus Vaccine, Live
    (MMR, Attenuvax)
    CL2
    Meningococcal Vaccine
    (Menomune, Menveo, Menactra)
    CL1
    Mumps Virus Vaccine, Live
    (MMR, Mumpsvax)
    XL3
    Pertussis VaccineCL2
    Pneumococcal Vaccine
    (Prevnar, Pneumovax 23, Pneuno 23, Pneumovax 23)
    CL1
    Polio Vaccine, Inactivated
    (Ipol)
    CL2
    Polio Vaccine, Oral
    (Vaccine-Live Oral Trivalent Polio)
    CL2
    Quadrivalent Human Papillmoavirus Vaccine
    (Gardasil)
    BL3
    Rabies Vaccine
    (Imovax Rabies Vaccine. RabAvert)
    CL3
    Rubella Virus Vaccine, Live
    (Meruvax, Rubella Vaccine, Measles Vaccine)
    XL2
    Smallpox Vaccine
    (Dryvax)
    CL4
    Tetanus Toxoid Vaccine
    (TE Anatoxal Berna)
    CL2
    Typhoid Vaccine
    (Vivotif Berna, Typhim Vi)
    CL3 (injectable)
    Varicella Virus Vaccine
    (Varivax, Chickenpox Vaccine, Varicella Vaccine)
    CL2
    Varicella-Zoster VaccineHazardousL4
    Yellow Fever Vaccine
    (YF-Vax, Arilvax, Stamaril)
    CL4
    Zoster Vaccine, Live
    (Zostavax)
    HazardousL3

     

    Pregnancy Risk Categories

    A. Controlled Studies Show No Risk

    Adequate, well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester of pregnancy.

    B. No Evidence of Risk in Humans

    Adequate, well-controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility.

    C. Risk Cannot Be Ruled Out

    Adequate,well-controlled human studies are lacking, and animal studies have shown a risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is administered during pregnancy, but the potential benefits may outweigh the potential risks.

    D. Positive Evidence of Risk

    Studies in humans, or investigational or post-marketing data, have demonstrated fetal risk. Nevertheless, potential benefits from the use of the drug may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

    X. Contraindicated in Pregnancy

    Studies in animals or humans, or investigational or post-marketing reports, have demonstrated positive evidence of fetal abnormalities or risks which clearly outweighs any possible benefit to the patient.

    Breastfeeding Risk Categories

    L1. Safest

    Drug which has been taken by a large number of breastfeeding mothers without any observed increase in adverse effects in the infant. Controlled studies in breastfeeding women fail to demonstrate a risk to the infant and the possibility of harm to the breastfeeding infant is remote, or the product is not orally bioavailable in an infant.

    L2. Safer

    Drug which has been studied in a limited number of breastfeeding women without an increase in adverse effects in the infant; and/or, the evidence of a demonstrated risk which is likely to follow use of this medication in a breastfeeding woman is remote.

    L3. Moderately Safe

    There are no controlled studies in breastfeeding women; however, the risk of untoward effects to a breastfed infant is possible; or, controlled studies show only minimal non-threatening adverse effects. Drugs should be given only if the potential benefit justifies the potential risk to the infant.

    L4. Possibly Hazardous

    There is positive evidence of risk to a breastfed infant or to breastmilk production, but the benefits of use in breastfeeding mothers may be acceptable despite the risk to the infant (e.g. if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

    L5. Contraindicated

    Studies in breastfeeding mothers have demonstrated that there is significant and documented risk to the infant based on human experience, or it is a medication that has a high risk of causing significant damage to an infant. The risk of using the drug in breastfeeding women clearly outweighs any possible benefit from breastfeeding. The drug is contraindicated in women who are breastfeeding an infant.

    Disclaimer: The information provided in this article is not meant to replace the professional medical advice from your health care provider. For detailed information on specific medications or for information on medications not listed, please consult your health care provider.

    References

    Hale, Thomas W. 2008. Medications and mothers’ milk, 13th edn. Amarillo, Texas: Hale Publishing.
    Hale, Thomas W. 2010. Medications and mothers’ milk, 14th edn. Amarillo, Texas: Hale Publishing.
    Hale, Thomas W. 2012. Medications and mothers’ milk, 15th edn. Amarillo, Texas: Hale Publishing.
    Safe Fetus: http://safefetus.com/index.php
    Search Medica RX: http://www.mims.com/USA

    Image Credits

    Smallpox Vaccine: http://commons.wikimedia.org/wiki/File:Smallpox_vaccine.jpg

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