Appendix 11. TB drugs in pregnant or breastfeeding women

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://doi.org/10.1093/cid/ciaa189 . 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://www.who.int/publications/i/item/9789240007048 (no absolute contra-indication).

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://doi.org/10.1093/cid/ciaa189 . 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://doi.org/10.1111/bcp.15380 [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 the 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://www.who.int/publications/i/item/9789240007048 .

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).

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/portfolio/compound/pretomanid#:~:text=Pretomanid%20is%20a%20nitroimidazole%2C%20a,part%20of%20the%20BPaL%20regimen. ).

P, Rfb

Not recommended during pregnancy and breastfeeding.