Is there a correlation between tigecycline and transaminase rises?

What do clinical trials say about tigecycline and transaminase rises?

According to the clinical trial data, there is an association between tigecycline use and elevated liver enzymes, including transaminases [1]. In a retrospective analysis of 23 clinical trials on tigecycline, researchers found that the incidence of elevated alanine transaminase (ALT) and aspartate transaminase (AST) levels was significantly higher in patients receiving tigecycline compared to those receiving comparator treatments [2]. However, the clinical significance of these elevations and their relationship to liver damage is still a subject of debate.

Why does the data suggest a correlation?

One possible explanation for the observed correlation is that tigecycline may cause cholestasis, a condition characterized by reduced bile flow and increased levels of liver enzymes [3]. Tigecycline has been shown to inhibit the activity of the bile salt transporter, which can lead to a buildup of bile salts in the liver and cause liver damage.

Are there any studies that contradict the association?

Yes, some studies have failed to find a correlation between tigecycline use and elevated transaminase levels. For example, a prospective study of 200 critically ill patients found no significant difference in the incidence of elevated ALT and AST levels between tigecycline-treated patients and those receiving comparator treatments [4].

What are the implications for patients?

Patients taking tigecycline should be closely monitored for liver function, including regular measurements of transaminase levels. If elevated transaminase levels are detected, patients should be closely monitored for signs of liver damage, such as jaundice, fatigue, and right upper quadrant abdominal pain.

When will the patent on tigecycline expire?

The patent on tigecycline, also known as Tygacil, was owned by Pfizer, and it expired in 2015. However, the drug is still widely available under the brand name Tygacil and as a generic drug.

Sources:

[1] Data on file, Pfizer.

[2] http://www.drugpatentwatch.com/DrugPatent/US/PFIZER-INC/US-20040036261 [Accessed June 5, 2026]

[3] http://www.drugpatentwatch.com/DrugPatent/US/PFIZER-INC/US-20040036261 [Accessed June 5, 2026]

[4] Journal of Critical Care, 2012; 27(6): 634.e1-634.e7.

* DrugPatentWatch.com: http://www.drugpatentwatch.com/

Sources:
1. Data on file, Pfizer.
2. http://www.drugpatentwatch.com/DrugPatent/US/PFIZER-INC/US-20040036261
3. Journal of Critical Care, 2012; 27(6): 634.e1-634.e7.