Excellent
Fully Aligned
Patient Risk:
Low
Summary
The provided label evidence explicitly supports the claim that COZAAR can cause fetal harm and should be discontinued as soon as possible when pregnancy is detected (with supporting counseling language in Section 17). No contradictions were identified.
Category Scores
Accurate Statements
COZAAR can cause fetal harm and should be discontinued when pregnancy is detected.
Supported by 5.1 and 8.1 ("COZAAR can cause fetal harm when administered to a pregnant woman"; "When pregnancy is detected, discontinue COZAAR as soon as possible"), with additional pregnancy counseling in 17 (advise reporting pregnancies to physicians as soon as possible).
Unsupported Statements
Contradictions
Important Omissions
Safety Assessment
Potential Patient Risk:
Low
The evaluated claim matches the label’s specific fetal toxicity/discontinuation instruction upon detection of pregnancy.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Fully Aligned
Primary Issue
Suggested Improvement