Appendix 11. Use of tuberculosis drugs in pregnant or breastfeeding women

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    Update: October 2022

     

    TB drugs

    Evidence and recommendations

    FQs

    For DR-TB: commonly used in pregnant women despite limited data. Associated with low birth weight in one observational study [1] Citation 1. Loveday M, Hughes J, Sunkari B, et al. Maternal and Infant Outcomes Among Pregnant Women Treated for Multidrug/Rifampicin-Resistant Tuberculosis in South Africa. Clin Infect Dis. 2021;72(7):1158-1168.
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8028100/pdf/ciaa189.pdf
    . As FQs reduce mortality from DR-TB, the benefits often outweigh the risks.

    Avoid breastfeeding if possible [2] Citation 2. World Health Organization. WHO consolidated guidelines on tuberculosis. Module 4: treatment - drug-resistant tuberculosis treatment. Geneva: World Health Organization; 2020.
    https://apps.who.int/iris/bitstream/handle/10665/332397/9789240007048-eng.pdf?sequence=1&isAllowed=y
    (no absolute contra-indication).

    For DS-TB: do not use the regimen 2HPZ-Mfx/2HP-Mfx in pregnant or breastfeeding women.

    Bdq

    No evidence of fetal harm in animal studies. Associated with low birth weight in one observational study [1] Citation 1. Loveday M, Hughes J, Sunkari B, et al. Maternal and Infant Outcomes Among Pregnant Women Treated for Multidrug/Rifampicin-Resistant Tuberculosis in South Africa. Clin Infect Dis. 2021;72(7):1158-1168.
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8028100/pdf/ciaa189.pdf
    . As Bdq reduces mortality from DR-TB, the benefits often outweigh the risks.

    Avoid breastfeeding if possible (high concentrations in human and animal breast milk) [3] Citation 3. Court et al. Bedaquiline exposure in pregnancy and breastfeeding in women with rifampicin-resistant tuberculosis; November 2021.
    https://www.authorea.com/doi/pdf/10.22541/au.163726220.09199594/v1
    [4] Citation 4. FDA product information Situro 2012 (bedaquiline).
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204384s000lbl.pdf
    .

    Lzd

    Few reported cases of use in pregnant women. Fetal harm in animal studies. As Lzd reduces mortality from DR-TB, the benefits often outweigh the risks.

    Avoid breastfeeding if possible (no data).

    Cfz

    Despite common use for leprosy and MDR-TB in pregnant women, few data on pregnancy outcomes. Fetal harm in animal studies.

    Use during pregnancy only if the benefits outweigh the risks.

    Avoid breastfeeding if possible (no data). If used, inform mother of possible (and reversible) skin discolouration of the breastfed infant.

    Cs, Trd

    Use during pregnancy only if the benefits outweigh the risks (no data).

    No contra-indication during breastfeeding.

    Dlm

    Use during pregnancy only if benefits outweigh the risks (limited human data, fetal harm in animal studies).

    Avoid breastfeeding if possible (high concentrations in animal breast milk).

    Ipm/Cln, Mpm

    Use during pregnancy and breastfeeding only if the benefits outweigh the risks (no data).

    Am, S

    Contra-indicated in pregnancy. No contra-indication during breastfeeding [2] Citation 2. World Health Organization. WHO consolidated guidelines on tuberculosis. Module 4: treatment - drug-resistant tuberculosis treatment. Geneva: World Health Organization; 2020.
    https://apps.who.int/iris/bitstream/handle/10665/332397/9789240007048-eng.pdf?sequence=1&isAllowed=y
    .

    Eto, Pto

    For DR-TB: contra-indicated in pregnancy (fetal harm in animal studies [5] Citation 5. World Health Organization. Companion handbook to the WHO guidelines for the programmatic management of drug-resistant tuberculosis. Geneva. 2014.
    https://apps.who.int/iris/bitstream/handle/10665/130918/9789241548809_eng.pdf;jsessionid=EFA574D0A45F34FAF833F58C2443130B?sequence=1
    ).

    In breastfeeding women, use only if the benefits outweigh the risks (limited data).

    For DS-TB: do not use the regimen 6HRZ-Eto in pregnant or breastfeeding women.

    PAS

    Use in pregnancy only if the benefits outweigh the risks (limited human data, no fetal harm in animal studies).

    Avoid breastfeeding if possible (no data).

    R, Z, H, E

    No contra-indication during pregnancy and breastfeeding.

    Pa

    Use during pregnancy and breastfeeding only if the benefits outweigh the risks (no human data, no fetal harm in animal studies [6] Citation 6. TB Alliance product information pretomanid 2019.
    https://www.tballiance.org/sites/default/files/assets/Pretomanid_Full-Prescribing-Information.pdf
    ).

    P, Rfb

    Not recommended during pregnancy and breastfeeding.

     

    For more specific recommendations for pregnant and breastfeeding women see Chapter 9, Chapter 10, and Appendix 10.

     

    References