The Safety of Antituberculosis Medications During Breastfeeding

Multidrug-resistant tuberculosis (MDR-TB) is a global public health problem affecting women of childbearing age. Little is known, however, about the safety of the drugs used to treat MDR-TB during pregnancy. We describe 7 patients who were treated for MDR-TB during pregnancy. These patients had chronic tuberculosis that had caused extensive parenchymal damage and had high-grade resistance to antituberculous drugs. All patients received individualized antituberculous therapy prior to delivery of healthy term infants. Neither obstetrical complications nor perinatal transmission of MDB-TB was observed. One patient experienced treatment failure, and another abandoned therapy. The other 5 patients are currently cured or in treatment and have culture-negative status. In each of these 7 cases, excellent treatment outcomes were obtained for the women and their children. Under certain circumstances, MDR-TB can be successfully treated during pregnancy.

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“…In terms of breast-feeding, most authors recommend breast- feeding, although recognizing that data are limited [61][62][63].…”

Section: Discussionmentioning

confidence: 96%

“…GI, gastrointestinal.According to the American Association of Pediatrics[23,63].Compared with therapeutic doses for infants[61,63].…”

mentioning

confidence: 99%

Treatment of Multidrug‐Resistant Tuberculosis during Pregnancy: A Report of 7 Cases

Shin

Guerra²,

Rich

et al. 2003

CLIN INFECT DIS

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“…However, this was confounded by the fact that smaller infants were more likely to receive breast milk. Antituberculosis drugs, including INH, are secreted in the breast milk of women on TB treatment, with levels ranging between 0.05 and 28% (32). The levels of antituberculosis drugs in breast milk are inadequate to prevent or treat infants but may increase the exposure to these medications.…”

Section: Discussionmentioning

confidence: 99%

“…The levels of antituberculosis drugs in breast milk are inadequate to prevent or treat infants but may increase the exposure to these medications. Therefore, Tran et al recommended dosing at the lower end of the therapeutic range (i.e., 10 mg/kg/ day of INH) in order to decrease the risk of potential toxicity (32).…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics of Isoniazid in Low-Birth-Weight and Premature Infants

Bekker

Schaaf

Seifart

et al. 2014

Antimicrob Agents Chemother

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dIsoniazid (INH) is recommended for use as posttuberculosis exposure preventive therapy in children. However, no pharmacokinetic data are available for INH treatment in low-birth-weight (LBW) infants, who undergo substantial developmental and physiological changes. Our objectives in this study were to determine the pharmacokinetic parameters of INH at a dose of 10 mg/kg of body weight/day and to define its pharmacokinetics relative to the arylamine N-acetyltransferase-2 (NAT2) genotype. An intensive prospective pharmacokinetic sampling study was conducted at Tygerberg Children's Hospital, South Africa, in which we measured INH blood plasma concentrations at 2, 3, 4 and 5 h postdose. Twenty LBW infants (14 male, 16 exposed to HIV) were studied. The median birth weight was 1,575 g (interquartile range, 1,190 to 2,035 g) and the median gestational age was 35 weeks (interquartile range, 34 to 38 weeks). The NAT2 acetylation statuses of the infants were homozygous slow (SS) (5 infants), heterozygous intermediate (FS) (11 infants), and homozygous fast (FF) (4 infants). Using a noncompartmental analysis approach, the median maximum drug concentration in blood serum (C max ) was 5.63 g/ml, the time after drug administration to reach C max T max ) was 2 h, the area under the concentration-time curve from 2 to 5 h (AUC 2-5 ) was 13.56 g · h/ml, the half-life (t 1/2 ) was 4.69 h, and the elimination constant rate (k el ) was 0.15 h ؊1 . The alanine aminotransferase levels were normal, apart from 2 isolated values at two and three times above the normal levels. Only the three-times-elevated value was repeated at 6 months and normalized. All LBW infants achieved target INH blood plasma concentrations comparable to the adult values. Reduced elimination was observed in smaller and younger infants and in slow acetylators, cautioning against higher doses. The safety data, although limited, were reassuring. More data, however, are required for newborn infants.

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“…The use of these first-line antituberculous drugs in pregnancy are considered safe for the mother and the baby by The British Thoracic Society, International Union Against Tuberculosis and Lung Disease, and the World Health Organisation [16, 45]. …”

Section: Treatment Of Tuberculosismentioning

confidence: 99%

Tuberculosis in Pregnancy: A Review

Loto

Awowole

2012

Journal of Pregnancy

136

128

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Tuberculosis (TB) was declared a public health emergency by WHO in 2005. The disease is a significant contributor to maternal mortality and is among the three leading causes of death among women aged 15–45 years in high burden areas. The exact incidence of tuberculosis in pregnancy, though not readily available, is expected to be as high as in the general population. Diagnosis of tuberculosis in pregnancy may be challenging, as the symptoms may initially be ascribed to the pregnancy, and the normal weight gain in pregnancy may temporarily mask the associated weight loss. Obstetric complications of TB include spontaneous abortion, small for date uterus, preterm labour, low birth weight, and increased neonatal mortality. Congenital TB though rare, is associated with high perinatal mortality. Rifampicin, INH and Ethambutol are the first line drugs while Pyrazinamide use in pregnancy is gaining popularity. Isoniazid preventive therapy is a WHO innovation aimed at reducing the infection in HIV positive pregnant women. Babies born to this mother should be commenced on INH prophylaxis for six months, after which they are vaccinated with BCG if they test negative. Successful control of TB demands improved living conditions, public enlightenment, primary prevention of HIV/AIDS and BCG vaccination.

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The Safety of Antituberculosis Medications During Breastfeeding

Cited by 34 publications

References 12 publications

Treatment of Multidrug‐Resistant Tuberculosis during Pregnancy: A Report of 7 Cases

Treatment of Multidrug‐Resistant Tuberculosis during Pregnancy: A Report of 7 Cases

Pharmacokinetics of Isoniazid in Low-Birth-Weight and Premature Infants

Tuberculosis in Pregnancy: A Review

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