Lofexidine Pregnancy and Breastfeeding Warnings

Brand names: Lucemyra

Lofexidine Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: The safety of this drug in pregnant women has not been established; in animal studies, exposures below what is expected in humans showed a reduction in fetal weights, increases in fetal resorptions, and litter loss.

Rabbits administered approximately 0.08 times the maximum recommended human dose (MRHD; based on AUC) from the beginning of organogenesis through lactation showed an increased incidence of resorptions, decreased number of implantations, and a concomitant reduction in the number of fetuses; maternal toxicity was observed at approximately 0.4 times the MRHD. Pregnant rats dosed at approximately 0.9 times the MRHD showed decreased implantations and decreased mean fetal weights; this dose was associated with maternal toxicity. At 0.2 times the MRHD (1.0 mg/kg/day), no malformations or evidence of developmental toxicity were observed. At doses higher than 0.2 times MRHD, surviving offspring exhibited lowered body weights, developmental delays, and increased delays in auditory startle. Sexual maturation was delayed in male offspring at 2 mg/kg/day and in female offspring at 1 mg/kg /day or higher. There are no controlled data in human pregnancy.

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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Lofexidine Breastfeeding Warnings

Use caution

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

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Further information

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