Excellent
Mostly Aligned
Patient Risk:
Low
Summary
All evaluated pregnancy/fetal toxicity elements in the provided claim match the supplied ALTACE/VOSTALLY label excerpts, including the boxed warning and the instruction to discontinue when pregnancy is detected.
Category Scores
Accurate Statements
Use of ALTACE/VOSTALLY (ramipril) in pregnancy is associated with fetal toxicity and fetal harm, including fetal renal function reduction and increased fetal/neonatal morbidity and death; discontinue as soon as pregnancy is detected.
Supported by ALTACE 5.6 (Fetal Toxicity) and 8.1 (Pregnancy), and VOSTALLY 5.1 (Fetal Toxicity) and 8.1 (Pregnancy), plus boxed warning language for both: discontinue as soon as pregnancy is detected; renin-angiotensin system–acting drugs can cause fetal injury and death; reduced fetal renal function and increased fetal/neonatal morbidity and death are described.
Unsupported Statements
Contradictions
Important Omissions
Safety Assessment
Potential Patient Risk:
Low
No contradictions or unsupported safety claims were identified for the evaluated fetal toxicity/discontinuation statement; it accurately reflects label boxed warning and pregnancy sections.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Suggested Improvement