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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 as a Whole|
|Hemic and Lymphatic System|
|Metabolic and Nutritional|
|Skin and Appendages|
|aVancomycin/Aztreonam, Imipenem/Cilastatin, Levofloxacin,
bLFT 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.
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 (see Table 2). The cause of the imbalance has not been established. Generally, deaths were the result of worsening infection, complications of infection or underlying co-morbidities.
Table 2: Patients with Outcome of Death by Infection
|Infection Type||TYGACIL n/N||%||Comparator n/N||%||Risk Difference* % (95% CI)|
|cSSSI||12/834||1.4||6/813||0.7||0.7 (-0.3, 1.7)|
|cIAI||42/1382||3.0||31/1393||2.2||0.8 (-0.4, 2.0)|
|CAP||12/424||2.8||11/422||2.6||0.2 (-2.0, 2.4)|
|HAP||66/467||14.1||57/467||12.2||1.9 (-2.4, 6.3)|
|Non-VAPa||41/336||12.2||42/345||12.2||0.0 (-4.9, 4.9)|
|VAPa||25/131||19.1||15/122||12.3||6.8 (-2.1, 15.7)|
|RP||11/128||8.6||2/43||4.7||3.9 (-4.0, 11.9)|
|DFI||7/553||1.3||3/508||0.6||0.7 (-0.5, 1.8)|
|Overall Adjusted||150/3788||4.0||110/3646||3.0||0.6 (0.1, 1.2)**|
|CAP = Community-acquired
pneumonia; cIAI = Complicated intra-abdominal infections; cSSSI = Complicated
skin and skin structure infections; HAP = Hospital-acquired pneumonia; VAP =
Ventilator-associated pneumonia; RP = Resistant pathogens; DFI = Diabetic foot
* The difference between the percentage of patients who died in TYGACIL and comparator treatment groups. The 95% CI for each infection type was calculated using the normal approximation method without continuity correction.
** Overall adjusted (random effects model by trial weight) risk difference estimate and 95% CI.
aThese are subgroups of the HAP population. Note: The studies include 300, 305, 900 (cSSSI), 301, 306, 315, 316, 400 (cIAI), 308 and 313 (CAP), 311 (HAP), 307 [Resistant gram-positive pathogen study in patients with MRSA or Vancomycin-Resistant Enterococcus (VRE)], and 319 (DFI with and without osteomyelitis).
In comparative clinical studies, infection-related serious adverse events were more frequently reported for subjects treated with TYGACIL (7%) versus comparators (6%). Serious adverse events of sepsis/septic shock were more frequently reported for subjects treated with TYGACIL (2%) versus comparators (1%). Due to baseline differences between treatment groups in this subset of patients, the relationship of this outcome to treatment cannot be established [see WARNINGS AND PRECAUTIONS].
The most common treatment-emergent adverse reactions were nausea and vomiting which generally occurred during the first 1 – 2 days of therapy. The majority of cases of nausea and vomiting associated with TYGACIL and comparators were either mild or moderate in severity. In patients treated with TYGACIL, nausea incidence was 26% (17% mild, 8% moderate, 1% severe) and vomiting incidence was 18% (11% mild, 6% moderate, 1% severe).
In patients treated for complicated skin and skin structure infections (cSSSI), nausea incidence was 35% for TYGACIL and 9% for vancomycin/aztreonam; vomiting incidence was 20% for TYGACIL and 4% for vancomycin/aztreonam. In patients treated for complicated intraabdominal infections (cIAI), nausea incidence was 25% for TYGACIL and 21% for imipenem/cilastatin; vomiting incidence was 20% for TYGACIL and 15% for imipenem/cilastatin. In patients treated for community-acquired bacterial pneumonia (CABP), nausea incidence was 24% for TYGACIL and 8% for levofloxacin; vomiting incidence was 16% for TYGACIL and 6% for levofloxacin. Discontinuation from tigecycline was most frequently associated with nausea (1%) and vomiting (1%). For comparators, discontinuation was most frequently associated with nausea ( < 1%).
The following adverse reactions were reported infrequently ( < 2%) in patients receiving TYGACIL in clinical studies:
Cardiovascular System: thrombophlebitis
Special Senses: taste perversion
Skin and Appendages: pruritus
Urogenital System: vaginal moniliasis, vaginitis, leukorrhea
The following adverse reactions have been identified during postapproval use of TYGACIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.
- anaphylaxis/anaphylactoid reactions
- acute pancreatitis
- hepatic cholestasis, and jaundice
- severe skin reactions, including Stevens-Johnson Syndrome
Read the Tygacil (tigecycline) Side Effects Center for a complete guide to possible side effects
Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective.
Read the Tygacil Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/10/2013
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