Poor
Not Aligned
Patient Risk:
Medium
Summary
While the general association of tigecycline with hepatic adverse effects (including elevated transaminases and isolated reports of hepatic failure) is supported, the majority of extracted claims add specificity (e.g., “most common” ALT/AST/ALP/bilirubin rankings and multiple higher-risk subgroups/mechanisms) that is not supported by the provided label sections.
Category Scores
Accurate Statements
Tigecycline has been associated with liver problems, including elevated liver enzymes and liver failure.
5.4 Hepatic Adverse Effects (transaminases/bilirubin/prothrombin time increases; isolated significant hepatic dysfunction and hepatic failure reported).
Unsupported Statements
According to the FDA, the most common liver-related adverse effects of tigecycline include elevated alanine aminotransferase (ALT).
Provided label does not state ALT or rank it as most common; transaminases are discussed generally.
According to the FDA, the most common liver-related adverse effects of tigecycline include elevated aspartate aminotransferase (AST).
Label shows SGOT (AST) increased in Table 1, but provided sections do not support a 'most common' ranking for AST among liver-related adverse effects.
According to the FDA, the most common liver-related adverse effects of tigecycline include elevated alkaline phosphatase (ALP).
Label shows alkaline phosphatase increased in Table 1, but provided sections do not support a 'most common' ranking for ALP among liver-related adverse effects.
According to the FDA, the most common liver-related adverse effects of tigecycline include elevated bilirubin.
Label mentions increased total bilirubin and provides bilirubinemia in Table 1, but provided sections do not support a 'most common' ranking for bilirubin.
Patients over 65 years old were more likely to experience liver enzyme elevations while taking tigecycline.
8.5 Geriatric Use states no overall differences in safety/effectiveness and greater sensitivity to adverse events generally cannot be ruled out; no statement about increased likelihood of liver enzyme elevations.
Patients with pre-existing liver disease (such as cirrhosis or liver cancer) are at a higher risk of liver problems with tigecycline.
5.4 provided section does not stratify risk by specific pre-existing liver conditions (e.g., cirrhosis or liver cancer).
A patient with cirrhosis developed severe liver failure after taking tigecycline.
5.4 states isolated cases of hepatic failure have been reported, but the provided label excerpt does not supply cirrhosis-specific case details.
Patients with renal impairment were more likely to experience liver enzyme elevations while taking tigecycline.
Provided 5.4 excerpt does not describe renal impairment as associated with liver enzyme elevations.
Patients with renal impairment are at a higher risk of liver problems with tigecycline due to potential accumulation in the body.
Provided label excerpt does not provide a mechanism linking renal impairment, accumulation, and increased hepatic risk.
Patients taking other medications that can affect the liver (such as acetaminophen or statins) are at a higher risk of liver problems with tigecycline.
5.4 notes some patients were receiving multiple concomitant medications, but does not identify hepatotoxic drug classes (acetaminophen/statins) or state increased risk tied to them.
Patients with malnutrition are at a higher risk of liver problems with tigecycline.
No malnutrition risk statement appears in the provided 5.4 excerpt.
Patients with malnutrition were more likely to experience liver enzyme elevations while taking tigecycline.
No malnutrition/enzymes linkage is supported by the provided label excerpts.
Older adults are more susceptible to liver problems with tigecycline due to decreased liver function and increased comorbidities.
8.5 does not assert increased susceptibility to liver problems specifically, nor does it provide the stated rationale.
Contradictions
Important Omissions
For statements about liver adverse effects, the label excerpt supports monitoring abnormal liver function tests and evaluating risk/benefit of continuing therapy; the extracted claims do not reflect these monitoring instructions.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Medium
Several extracted claims create unsupported higher-risk subgroup assertions and stronger-than-labeled frequency ('most common') rankings, which could mislead risk assessment relative to the provided label excerpts.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Over-specific and ranked claims (ALT/AST/ALP/bilirubin as 'most common') and multiple higher-risk population/mechanism claims are not supported by the provided label text.
Suggested Improvement
Restrict statements to what the label excerpt supports: general hepatic adverse effects (bilirubin, prothrombin time, transaminases), isolated hepatic dysfunction/failure, monitoring for worsening hepatic function and risk/benefit evaluation of continuation, and that some patients had multiple concomitant medications. Remove unsupported subgroup risk/mechanism claims (renal impairment accumulation, pre-existing cirrhosis/liver cancer risk, acetaminophen/statins linkage, malnutrition, and older-adult liver susceptibility rationale) unless additional label sections are provided.