Tygacil Warnings

An increase in all-cause mortality has been observed across phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator-treated patients. In a pooled analysis of all 13 phase 3 and 4 trials that included a comparator, death occurred in 4% (150/3788) of patients receiving tigecycline and 3% (110/3646) of patients receiving comparator drugs resulting in an unadjusted risk difference of 0.9% (95% CI 0.1, 1.8). In a pooled analysis of these trials, based on a random effects model by trial weight, an adjusted risk difference of all-cause mortality was 0.6% (95% CI 0.1, 1.2) between tigecycline- and comparator-treated patients. The cause of this increase has not been established. This increase in all-cause mortality should be considered when selecting among treatment options. (See Precautions and Adverse Reactions.)
Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening.
Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics. Therefore, tigecycline should be administered with caution in patients with known hypersensitivity to tetracycline class antibiotics.
Results of studies in rats with tigecycline have shown bone discoloration. Tigecycline may be associated with permanent teeth discoloration in humans during tooth development.
Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of any antibacterial agent.