Good
Mostly Aligned
Patient Risk:
Low
Summary
The listed all-cause mortality/boxed-warning content is supported by the provided FDA label sections. However, multiple other claims in the set are not supported by the supplied label excerpts (and some contraindication-related statements are not supported/are outside the provided text), reducing overall alignment for the full list.
Category Scores
Accurate Statements
An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in TYGACIL-treated patients versus comparator.
BOXED WARNING — ALL-CAUSE MORTALITY; 5.1 All-Cause Mortality
The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established.
BOXED WARNING — ALL-CAUSE MORTALITY; 5.1 All-Cause Mortality
Unsupported Statements
According to the FDA, tigecycline is contraindicated in patients with liver dysfunction.
No contraindication for liver dysfunction is present in the provided label excerpts (boxed warning/all-cause mortality and pneumonia mortality imbalance).
According to the FDA, tigecycline is contraindicated in patients taking other medications that may interact with tigecycline.
No contraindication for interacting medications is present in the provided label excerpts.
Tigecycline is approved for the treatment of complicated skin and skin structure infections (cSSSI).
The provided excerpts include limitations of use and warnings but do not list approvals/indications text beyond referencing cSSSI/cIAI/CABP in mortality analyses.
Tigecycline is approved for the treatment of community-acquired bacterial pneumonia (CABP).
The provided excerpts do not include the actual CABP indication/approval statement; only mortality analyses reference CABP.
Tigecycline binds to the 30S subunit of the bacterial ribosome.
No mechanism-of-action details are present in the provided label excerpts.
Tigecycline inhibits protein synthesis.
No mechanism-of-action details are present in the provided label excerpts.
Tigecycline leads to bacterial death.
No mechanistic or efficacy statements in the provided label excerpts support this.
Tigecycline is effective against MRSA/VRE/ESBL-producing bacteria.
No spectrum-of-activity or efficacy claims are supported by the provided label excerpts.
In a study for complicated skin and skin structure infections, tigecycline had a cure rate of 92.3% in patients with MRSA.
No cure-rate data are provided in the supplied label excerpts.
A phase III trial reported tigecycline was effective in treating complicated intra-abdominal infections (cIAI).
No cIAI efficacy trial details are provided in the supplied label excerpts.
In complicated intra-abdominal infections (cIAI), tigecycline had a cure rate of 83.3%.
No cure-rate data are provided in the supplied label excerpts.
In complicated intra-abdominal infections (cIAI), the comparator antibiotic had a cure rate of 73.6%.
No cure-rate data are provided in the supplied label excerpts.
Common side effects of tigecycline include nausea/vomiting/diarrhea.
No adverse event incidence list for common side effects is provided in the supplied label excerpts.
More serious adverse events reported with tigecycline include thrombocytopenia.
No thrombocytopenia content is provided in the supplied label excerpts.
More serious adverse events reported with tigecycline include liver function abnormalities.
No liver function abnormality content is provided in the supplied label excerpts.
Tigecycline's patent expired in 2015.
Patent/generic-market statements are not contained in the supplied FDA label excerpts.
Generic versions of tigecycline entered the market after patent expiration in 2015.
Generic-market statements are not contained in the supplied FDA label excerpts.
Several generic manufacturers received FDA approval to market tigecycline, including Sandoz/Teva/Mylan.
Generic-market statements are not contained in the supplied FDA label excerpts.
Tigecycline has demonstrated excellent efficacy against MRSA in clinical trials.
No efficacy summary is provided in the supplied label excerpts.
Several generic manufacturers have received FDA approval to market tigecycline.
Generic-market statements are not contained in the supplied FDA label excerpts.
Contradictions
Low
AI Statement
According to the FDA, tigecycline is contraindicated in patients with liver dysfunction.
Label Reference
Provided excerpts contain no contraindication for liver dysfunction; contradiction cannot be confirmed from the supplied text.
Important Omissions
The response list does not explicitly include the boxed-warning quantitative death rates (4.0% vs 3.0%) and the mortality reserve/use statement for alternative treatments being not suitable.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
Only the all-cause mortality/boxed-warning portion is clearly supported by the provided label excerpts. Other statements include at least two contraindication-related claims that are not supported by the supplied label text, which could mislead safety interpretation if relied upon.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Mostly Aligned
Primary Issue
Multiple statements in the provided list are not supported by the supplied FDA label excerpts (mechanism, indications, efficacy/cure rates, common adverse events, contraindications, and generic/patent claims). Only the all-cause mortality boxed-warning content is clearly supported.
Suggested Improvement
Restrict safety statements to what is explicitly present in the provided label excerpts, and remove or qualify contraindication, mechanism, efficacy, cure-rate, and common/serious adverse event claims unless the full corresponding label sections are supplied.