Fexinidazole Pregnancy and Breastfeeding Warnings

Fexinidazole Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: Not assigned.

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Disease-associated maternal and/or embryo/fetal risk should be considered.

Animal studies have revealed evidence of fetotoxicity and fetal loss at maternotoxic doses. After pregnant rats were exposed to this oral drug during organogenesis, no effect on prenatal development was seen at up to 200 mg/kg/day (a dose similar to the clinical dose based on AUC comparisons); at 800 mg/kg, maternal toxicity (significantly reduced body weight gain) was observed and associated with delayed ossification (sternebrae, metacarpals, and caudal vertebrae) and reduced fetal and placental weights. After pregnant rabbits were exposed to this drug during organogenesis at doses at least 20 mg/kg/day (less than 0.02 times the clinical exposures, based on pharmacokinetic comparisons), maternal toxicity (reduced food intake and reduced body weight gain) was observed which resulted in abortions. There are no controlled data in human pregnancy.

Untreated human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in pregnancy is associated with adverse effects on maternal and fetal outcomes. The disease may progress during pregnancy. Pregnant patients should be treated for HAT due to T brucei gambiense during pregnancy to prevent vertical transmission; for timing of treatment during pregnancy, the benefits of this drug to the mother and the potential risks to the fetus should be considered.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Fexinidazole Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

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