Poor
Not Aligned
Patient Risk:
High
Summary
Several key safety-related claims are unsupported by the provided label text (e.g., common side effects, renal impairment/kidney damage, cardiovascular/MI/stroke associations, monitoring and antibiotic-combination guidance). Some dose-excess (“in excess”) causality claims are only partially supported because the label describes CDAD/hepatic adverse effects with tigecycline use rather than an overdose/excess-dose relationship.
Category Scores
Accurate Statements
Tigecycline is used to treat complicated skin and skin structure infections.
1.1 Complicated Skin and Skin Structure Infections
Tigecycline is used to treat intra-abdominal infections.
1.2 Complicated Intra-abdominal Infections (claim phrasing is broader than label’s “complicated”)
Tigecycline is used to treat community-acquired bacterial pneumonia.
1.3 Community-Acquired Bacterial Pneumonia
Tigecycline can disrupt the balance of gut bacteria.
5.9 Clostridioides difficile-Associated Diarrhea (alters normal flora)
Gut bacterial disruption from tigecycline can lead to overgrowth of C. diff.
5.9 Clostridioides difficile-Associated Diarrhea (overgrowth of C. difficile after flora alteration)
Taking tigecycline in excess can increase the risk of Clostridioides difficile (C. diff) infection.
5.9 CDAD reported with use of antibacterial agents including TYGACIL; provided label text does not establish an “excess dose” causality
Tigecycline in excess has been linked to hepatotoxicity.
5.4 Hepatic Adverse Effects (hepatic dysfunction/failure reported); label text does not establish “in excess”/overdose linkage
Excessive tigecycline use can cause elevated liver enzymes.
5.4 Hepatic Adverse Effects (increases in transaminases seen); dose-excess linkage not established
Unsupported Statements
Tigecycline is a glycylcycline antibiotic that works by inhibiting protein synthesis in bacteria.
Label excerpt provided (12.1) describes tigecycline as a tetracycline class antibacterial but does not include the specific “inhibiting protein synthesis” mechanism statement in the provided text.
Tigecycline is available in the United States under the brand name Tygacil.
No such support is present in the provided label excerpts.
The most common side effects of tigecycline include nausea.
No “most common side effects” list (including nausea) is present in the provided label excerpts.
The most common side effects of tigecycline include vomiting.
No “most common side effects” list (including vomiting) is present in the provided label excerpts.
The most common side effects of tigecycline include diarrhea.
No “most common side effects” list is present in the provided label excerpts.
The most common side effects of tigecycline include abdominal pain.
No “most common side effects” list is present in the provided label excerpts.
Tigecycline can cause renal impairment.
No renal impairment/kidney damage information is present in the provided label excerpts.
Tigecycline can cause kidney damage.
No kidney damage information is present in the provided label excerpts.
Tigecycline can cause kidney damage particularly in patients with pre-existing kidney disease.
No kidney disease/predisposition information is present in the provided label excerpts.
Excessive tigecycline use has been associated with an increased risk of cardiovascular events.
No cardiovascular association content is present in the provided label excerpts.
Excessive tigecycline use has been associated with an increased risk of myocardial infarction.
No myocardial infarction association content is present in the provided label excerpts.
Excessive tigecycline use has been associated with an increased risk of stroke.
No stroke association content is present in the provided label excerpts.
Patients should be monitored for signs of adverse effects such as nausea, vomiting, and diarrhea.
No monitoring recommendation for these specific symptoms is present in the provided label excerpts.
Avoiding concurrent use with other antibiotics can reduce the risk of adverse effects.
No label support for avoiding concurrent antibiotics or reducing adverse effects by doing so is present in the provided label excerpts.
Combining tigecycline with other antibiotics can increase the risk of adverse effects.
No label support for increased risk when combined with other antibiotics is present in the provided label excerpts.
Tigecycline's patent expired in 2015, making it a generic medication.
No patent/generic status information is present in the provided label excerpts.
A study reported a case of tigecycline-associated hepatotoxicity in a 45-year-old woman.
No case report or age-specific study details are present in the provided label excerpts.
In the reported case, the patient had been taking tigecycline for 14 days.
No such case details are present in the provided label excerpts.
In the reported case, the patient developed elevated liver enzymes.
No such case details are present in the provided label excerpts.
In the reported case, switching the patient to a different antibiotic resulted in liver function returning to normal.
No such case details are present in the provided label excerpts.
Contradictions
Important Omissions
Boxed warning details (All-Cause Mortality and Mortality Imbalance/Lower Cure Rates in Hospital-Acquired Pneumonia) and their related labeling context.
Importance:
Moderate
Warfarin interaction monitoring (prothrombin time/appropriate anticoagulation testing) when tigecycline is administered with warfarin.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
High
Unsupported safety claims (e.g., renal impairment/kidney damage; cardiovascular/MI/stroke associations) and incorrect/unsupported dose-excess framing for CDAD/hepatic adverse effects reduce label fidelity and could mislead risk communication. Additional omission of boxed warning content further weakens safety alignment.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Not Aligned
Primary Issue
Multiple adverse effect and monitoring claims are not supported by the provided label text, and several dose-excess (“in excess”) causality claims are not established by the label excerpts.
Suggested Improvement
Restrict statements to label-supported content in the provided sections: use 1.1/1.2/1.3 for indications; use 5.9 for CDAD mechanism without implying overdose/excess dosing; use 5.4 for hepatic adverse effects without dose-excess framing; omit or replace unsupported claims (renal, cardiovascular/MI/stroke, common side effects lists, monitoring for nausea/vomiting/diarrhea, antibiotic-combination guidance, generic/patent and case-study details). Include boxed warning and warfarin interaction monitoring language when relevant.