Excellent
Mostly Aligned
Patient Risk:
Low
Summary
Claims about CALDOLOR/ibuprofen cardiovascular thrombotic risk, serious GI risks, lack of consistent CV risk mitigation with concurrent aspirin, increased GI risk with aspirin+ibuprofen, and CABG contraindication are supported by the provided FDA label excerpts.
Category Scores
Accurate Statements
CALDOLOR/ibuprofen increases the risk of serious cardiovascular thrombotic events (including MI and stroke), which can be fatal; risk may occur early and may increase with duration of use.
5.1 Cardiovascular Thrombotic Events
NSAIDs including ibuprofen cause serious gastrointestinal adverse events (inflammation, bleeding, ulceration, and perforation) which can be fatal, and these can occur at any time with or without warning symptoms.
5.2 Gastrointestinal Bleeding, Ulceration, and Perforation
There is no consistent evidence that concurrent use of aspirin mitigates NSAID-associated increased risk of serious cardiovascular thrombotic events; concurrent aspirin and an NSAID such as ibuprofen increases risk of serious gastrointestinal events.
5.1 Cardiovascular Thrombotic Events; 7 Drug Interactions (Aspirin); 5.2 Gastrointestinal Bleeding, Ulceration, and Perforation
Use in the setting of coronary artery bypass graft (CABG) surgery is contraindicated.
4 Contraindications (CABG surgery)
Unsupported Statements
Evaluation is limited to the provided label sections.
This is a meta statement about the evaluation process, not a label claim.
Contradictions
Important Omissions
Safety Assessment
Potential Patient Risk:
Low
No label-inconsistent or contradictory safety statements were made relative to the provided sections; all substantive risk communications assessed were supported.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Suggested Improvement