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Tigecycline Pregnancy and Breastfeeding Warnings

Tigecycline is also known as: Tygacil

Tigecycline Pregnancy Warnings

Animal studies have revealed evidence of fetal harm. Tigecycline crossed the placenta and was found in fetal tissues (including bony structures). Fetal weight reductions and increased incidence of skeletal anomalies (delayed bone ossification) were observed at exposures 5 times and equal to the daily human dose based on AUC in rats and rabbits, respectively. Increased incidence of fetal loss was found at maternotoxic doses in rabbits (exposure equal to human dose). There are no controlled data in human pregnancy. Tigecycline use during tooth development (second half of pregnancy) may cause permanent yellow-gray-brown discoloration of the teeth. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: D Tigecycline should be used during pregnancy only if the benefit outweighs the risk to the fetus. Comments: -Tigecycline should not be used during tooth development unless other drugs contraindicated or unlikely to be effective. -Women who become pregnant during therapy should be advised of the potential hazard to the fetus.

Tigecycline Breastfeeding Warnings

There are no data on the excretion of tigecycline into human milk. It is readily excreted into rat milk; however, due to its limited oral bioavailability, minimal or no systemic exposure occurred in pups. Caution is recommended if tigecycline is administered to a breast-feeding woman.

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