6.3.3 Pregnant and lactating women

Dosing and safety data to support the optimal use of second-line TB medicines during pregnancy are generally sparse. There have been case reports and observational data reporting successful treatment and pregnancy outcomes among women who received treatment (including bedaquiline-containing regimens) for MDR/RR-TB during pregnancy and postpartum, but pregnant and lactating women are usually excluded from clinical drug trials and early access programmes. Even less is known about the effects of MDR/RR-TB treatment on the infant in-utero and after birth; however, in general, the benefits (to both parent and child) of providing effective MDR/RR-TB treatment to the parent far outweigh the potential risks posed to the fetus in-utero or the breastfed infant.

Ethionamide is usually contraindicated in pregnancy because animal reproduction studies have shown an adverse effect on the fetus, and there are no adequate and well-controlled studies in humans. The adverse effects of linezolid may be exacerbated by the physiological effects of pregnancy, which lead to a relatively low haemoglobin (due to the dilutional effect of increased blood volume) and a higher risk of peripheral neuropathies at treatment baseline compared with nonpregnant patients. Nevertheless, linezolid may be considered for pregnant and lactating patients. More compelling evidence on the dosing and safety of specific anti-TB drugs among pregnant and lactating women is needed to guide decision-making on the most appropriate regimen for treatment of MDR/RR-TB during pregnancy and postpartum. Amikacin and streptomycin are considered teratogenic and should be avoided during pregnancy. They should be considered only if there is no other option and the lives of the pregnant person and fetus are at risk.

Pregnant and breastfeeding women require considerable adherence support and monitoring of proper administration of MDR/RR-TB treatment, along with other chronic medications, to ensure successful treatment outcomes and minimal risk of TB transmission from mother to infant postpartum. Care providers must also pay particular attention to seamless continuity of care between antenatal and TB services; such services are rarely integrated in TB-endemic settings (50).

Considerations on the use of TB medication during pregnancy are given in Web Annex 1.

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