rinfection
As with other antibacterial drugs, use of TYGACIL may result in overgrowth of non-susceptible organisms, including fungi. Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken.
5.11 Development of Drug-Resistant Bacteria
Prescribing TYGACIL in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, 2514 patients were treated with TYGACIL. TYGACIL was discontinued due to adverse reactions in 7% of patients compared to 6% for all comparators. Table 1 shows the incidence of treatment-emergent adverse reactions through test of cure reported in ≥2% of patients in these trials.
Table 1. Incidence (%) of Adverse Reactions Through Test of Cure Reported in ≥ 2% of Patients Treated in Clinical Studies
Body System
Adverse Reactions TYGACIL
(N=2514) Comparatorsa
(N=2307)
a Vancomycin/Aztreonam, Imipenem/Cilastatin, Levofloxacin, Linezolid.
b LFT abnormalities in TYGACIL-treated patients were reported more frequently in the post therapy period than those in comparator-treated patients, which occurred more often on therapy.
Body as a Whole
Abdominal pain 6 4
Abscess 3 3
Asthenia 3 2
Headache 6 7
Infection 8 5
Cardiovascular System
Phlebitis 3 4
Digestive System
Diarrhea 12 11
Dyspepsia 2 2
Nausea 26 13
Vomiting 18 9
Hemic and Lymphatic System
Anemia 4 5
Metabolic and Nutritional
Alkaline Phosphatase
Increased 4 3
Amylase Increased 3 2
Bilirubinemia 2 1
BUN Increased 3 1
Healing Abnormal 4 3
Hypoproteinemia 5 3
SGOT Increasedb 4 5
SGPT Increasedb 5 5
Nervous System
Dizziness 3 3
Skin and Appendages
Rash 3 4
In all Phase 3 and 4 studies that included a comparator, death occurred in 3.9% (147/3788) of patients receiving TYGACIL and 2.9% (105/3646) of patients receiving comparator drugs. In a pooled analysis of these studies, the risk difference of all-cause mortality was 1.0% (95% CI 0.2, 1.8) between TYGACIL and comparator treated patients. Within the approved indications only (cSSSI, cIAI, CAP), the risk difference was 0.7% (95% CI -0.0, 1.6) between TYGACIL and comparator treated patients, and for the unapproved indications the risk diff |
