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Trovafloxacin Pregnancy and Breastfeeding Warnings

Trovafloxacin is also known as: Trovan

Trovafloxacin Pregnancy Warnings

Of 549 cases reported by the European Network of Teratology Information Services involving exposure to other fluoroquinolones, congenital malformations were reported in 4.8%; however, this was not higher than the background rate.

Trovafloxacin has been assigned to pregnancy category C by the FDA. Some animal studies failed to reveal evidence of fetal harm. However, studies using high doses demonstrated fetotoxicity and teratogenicity (increased perinatal mortality, decreased body weight and cartilage damage and arthropathies that have suggested abnormal fetal bone formation). There are no controlled data from human pregnancy studies. Because safer alternatives are available, some experts consider fluoroquinolones contraindicated during pregnancy, especially during the first trimester. The manufacturer recommends that trovafloxacin should only be given during pregnancy when benefit outweighs risk.

Trovafloxacin Breastfeeding Warnings

Trovafloxacin is excreted into human milk. Quinolone-induced cartilage erosion and arthropathies that have been observed in juvenile animals render some concern over its possible toxic effects on the developing joints of nursing infants. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Trovafloxacin was detectable in the breast milk of three lactating women. The average breast milk concentration was 0.8 mcg/mL (range 0.3 to 2.1 mcg/mL) after single intravenous alatrofloxacin 300 mg and repeated oral trovafloxacin 200 mg doses.

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