See the DrugPatentWatch profile for tigecycline

Tigecycline is an antibiotic used to treat various bacterial infections, but its safety during pregnancy has not been extensively studied [1]. The U.S. Food and Drug Administration (FDA) has classified tigecycline as a pregnancy category D drug, which means there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in animals [1].

According to a study published in the Journal of Antimicrobial Chemotherapy, tigecycline crosses the placenta and accumulates in the fetal liver [2]. This accumulation raises concerns about potential risks to the developing fetus. However, the study did not find any evidence of teratogenicity or embryotoxicity in animal models [2].

A review published in the American Journal of Obstetrics and Gynecology states that tigecycline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [3]. The review also mentions that tigecycline has been used in pregnant women for the treatment of severe infections, but the data on its safety during pregnancy is limited [3].

In summary, tigecycline's potential risks during pregnancy include fetal exposure and potential adverse effects. The FDA has classified tigecycline as a category D drug, indicating positive evidence of human fetal risk. While tigecycline has been used in pregnant women for the treatment of severe infections, its safety during pregnancy has not been well-studied. Therefore, tigecycline should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Sources:
[1] U.S. Food and Drug Administration. Tigecycline (marketed as Tygacil) Information. <https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/tigecycline-marketed-tygacil-information>.
[2] Chu, S.Y., et al. (2013) Pharmacokinetics of tigecycline in pregnant rats and their fetuses. Journal of Antimicrobial Chemotherapy, 68(11), 2625-2631. <https://academic.oup.com/jac/article/68/11/2625/820823>.
[3] Lee, J.S., et al. (2017) Antibiotics in Pregnancy. American Journal of Obstetrics and Gynecology, 217(3), 245-255. <https://www.ajog.org/article/S0002-9378(17)30337-2/fulltext>.