Label Changes for:
Tygacil (tigecycline) for Injection
Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- information from meta-analysis of clinical trials that showed an increased risk of mortality in Tygacil-treated patients and to reserve Tygacil for use in situations when alternative treatments are not suitable.
5 WARNINGS AND PRECAUTIONS
5.1 All-Cause Mortality
- added ..... increased risk of mortality.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
- increase in mortality in trials conducted for approved indications
6.2 Post-Marketing Experience
- added ...Stevens-Johnson syndrome and symptomatic hypoglycemia
- Revised the incidence of adverse reactions in Table 1.
8 USE IN SPECIFIC POPULATIONS
8.4 Pediatric Use
- added ..... information about use in the pediatric population.
WARNINGS and PRECAUTIONS
- An increase in all-cause mortality has been observed across Phase 3 and 4 clinical trials in Tygacil-treated patients versus comparator-treated patients. In all 13 Phase 3 and 4 trials that included a comparator, death occurred in 4.0% (150/3788) of patients receiving Tygacil and 3.0% (110/3646) of patients receiving comparator drugs. 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 Tygacil 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.
Mortality Imbalance and Lower Cure Rates in Ventilator-Associated Pneumonia
- In this trial, greater mortality was seen in patients with ventilator-associated pneumonia who received Tygacil (25/131 [19.1%] versus 15/122 [12.3%] in comparator-treated patients). Particularly high mortality was seen among Tygacil-treated patients with ventilator-associated pneumonia and bacteremia at baseline (9/18 [50.0%] versus 1/13 [7.7%] in comparator-treated patients).
- Acute pancreatitis, including fatal cases, has occurred in association with tigecycline treatment. The diagnosis of acute pancreatitis should be considered in patients taking tigecycline who develop clinical symptoms, signs, or laboratory abnormalities suggestive of acute pancreatitis. Cases have been reported in patients without known risk factors for pancreatitis. Patients usually improve after tigecycline discontinuation. Consideration should be given to the cessation of the treatment with tigecycline in cases suspected of having developed pancreatitis.
Clinical Trials Experience
- In all 13 Phase 3 and 4 trials that included a comparator, death occurred in 4.0% (150/3788) of patients receiving Tygacil and 3.0% (110/3646) of patients receiving comparator drugs. 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 Tygacil and comparator-treated patients. The cause of the imbalance has not been established. Generally, deaths were the result of worsening infection, complications of infection or underlying co-morbidities.