Excellent
Aligned
Patient Risk:
Low
Summary
The evaluated claim is fully supported by the provided ENTRESTO label sections on fetal toxicity/pregnancy, including fetal renal effects, increased fetal/neonatal morbidity and death with 2nd/3rd trimester exposure, discontinuation when pregnancy is detected, and counseling.
Category Scores
Accurate Statements
ENTRESTO can cause fetal harm in pregnancy, including fetal renal effects and increased fetal/neonatal morbidity and death when used in the 2nd and 3rd trimesters; discontinue when pregnancy is detected and counsel about risk.
Supported by 5.1 (Fetal Toxicity) and 8.1 (Pregnancy Risk Summary/Clinical Considerations), which state fetal harm, reduced fetal renal function, and increased fetal/neonatal morbidity and death with 2nd/3rd trimester exposure; also supported by 8.1 recommendation to discontinue when pregnancy is detected and 17 (Patient Counseling Information) advising counseling about consequences of exposure during pregnancy.
Unsupported Statements
Contradictions
Important Omissions
Safety Assessment
Potential Patient Risk:
Low
No unsupported or contradictory safety claims were made; the statement aligns with label warnings and counseling regarding fetal toxicity.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Aligned
Primary Issue
Suggested Improvement