5.3.3 Pregnant and breastfeeding 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 breastfeeding 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 physiologic 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, may be exacerbated by the adverse effects of linezolid. Nevertheless, the 9-month all-oral regimen including linezolid instead of ethionamide may be considered for pregnant and breastfeeding patients who meet the eligibility criteria for the shorter regimen with linezolid, although closer monitoring is required.

More compelling evidence on the dosing and safety of specific anti-TB drugs among pregnant and breastfeeding women is needed to guide decision-making on the most appropriate regimen for treatment of MDR/RR-TB during pregnancy and postpartum. In addition, this population group requires 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, which are rarely integrated in most TB-endemic settings. In view of the complexities of service integration, the challenges in clinical management, and the scarcity of evidence-based recommendations for this group, The Sentinel Project on Pediatric Drug-Resistant Tuberculosis7 brought together a group of providers and researchers with decades of experience caring for people with DR-TB who are pregnant or in the peripartum period. This group developed a “field guide” that is intended to supplement existing guidelines and constitutes a set of current best practices to improve the quality of care provided to pregnant and postpartum individuals, and their infants, who are living with DR-TB (50).

7 See https://sentinel-project.org/.

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