Fosfomycin Pregnancy and Breastfeeding Warnings

Fosfomycin is also known as: Monurol

Fosfomycin Pregnancy Warnings

Fosfomycin has been assigned to pregnancy category B by the FDA. Animal studies have revealed evidence of fetotoxicity, but only at dosages which also resulted in maternal toxicity. Intramuscularly administered fosfomycin sodium crosses the placental barrier. There are no controlled data in human pregnancy. Fosfomycin is only recommended for use during pregnancy when benefit outweighs risk.

Fosfomycin has been shown to cross the placental barrier in humans. At dosages 1.4 and 9 times the human dose, no teratogenic effects were observed in rats. When given to rabbits at 2.7 and 9 times the human dose, fetotoxicities were observed, but maternal toxicity was also present. These toxicities are considered to be changes in intestinal microflora according to the manufacturer. Fosfomycin tromethamine 3 grams orally in water was given to 153 pregnant women with bacteriuria as a single dose. Infecting organisms were eradicated in 96% of patients, with a recurrence rate of 3% after 25 to 30 days. Minimal maternal side effects occurred and no serious adverse fetal effects were documented. The trimester in which the medication was administered was not reported.

Fosfomycin Breastfeeding Warnings

There are no data on the excretion of fosfomycin into human milk. Excretion is expected due to its low molecular weight. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Due to the fact that fosfomycin is given in a single dose, breast-feeding should be able to be safely resumed within 36 to 48 hours after administration, although studies supporting this suggestion are not currently available.

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