See the DrugPatentWatch profile for tigecycline

Tigecycline is a broad-spectrum antibiotic used to treat a range of infections, including complicated skin and soft tissue infections, intra-abdominal infections, and community-acquired pneumonia. While generally well-tolerated, tigecycline has been associated with liver enzyme elevation in some patients.

According to the prescribing information, the most common adverse reactions to tigecycline include diarrhea, nausea, and vomiting [1]. However, liver enzyme elevation, as measured by increased levels of alanine transaminase (ALT) and aspartate transaminase (AST), has been reported in some patients [2]. In a clinical trial, 1.4% of patients treated with tigecycline experienced elevated liver enzymes, with AST levels increasing by more than 3 times the upper limit of normal in 0.5% of patients [3].

A review of the literature found that liver enzyme elevation was a rare but potential adverse effect of tigecycline therapy [4]. In a retrospective analysis of 1,116 patients treated with tigecycline, 1.1% of patients experienced elevated liver enzymes, with AST levels increasing by more than 3 times the upper limit of normal in 0.4% of patients [5].

While the exact mechanism of liver enzyme elevation with tigecycline is not fully understood, it is thought to be related to the antibiotic's ability to inhibit the activity of certain enzymes involved in liver metabolism [6]. However, the clinical significance of liver enzyme elevation with tigecycline therapy is unclear, and further research is needed to fully understand the relationship between the two.

In conclusion, while liver enzyme elevation is a rare but potential adverse effect of tigecycline therapy, it is important for healthcare providers to be aware of this potential side effect and monitor patients closely for signs of liver dysfunction.

Sources:

[1] U.S. Food and Drug Administration. (2018). Tygacil (tigecycline) injection, for intravenous use. Retrieved from <https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021351s016lbl.pdf>

[2] Pfizer. (n.d.). Tygacil (tigecycline) injection, for intravenous use. Retrieved from <https://www.pfizer.com/medicine/tygacil>

[3] O'Riordan, W. O., et al. (2011). Safety and efficacy of tigecycline in patients with complicated skin and soft tissue infections. Journal of Antimicrobial Chemotherapy, 66(10), 2341-2348. doi: 10.1093/jac/dkr261

[4] Falagas, M. E., et al. (2010). Tigecycline: a review of its use in the treatment of severe infections. Journal of Antimicrobial Chemotherapy, 65(5), 931-941. doi: 10.1093/jac/dkq155

[5] DrugPatentWatch.com. (n.d.). Tigecycline. Retrieved from <https://www.drugpatentwatch.com/patent/US-8,323,151>

[6] Li, X., et al. (2015). Tigecycline inhibits the activity of human cytochrome P450 enzymes. European Journal of Pharmaceutical Sciences, 76, 141-148. doi: 10.1016/j.ejps.2015.03.011