Partial
Partially Aligned
Patient Risk:
Low
Summary
The smoking/age >35 and smoking risk content is supported by the label excerpts (boxed warning, contraindications language, warnings, and patient counseling), but the specific phrasing of the claim as 'contraindicated if over age 35 and smoking' is not matched with clear, exact contraindications wording in the provided evaluation/citations, making the alignment only partial.
Category Scores
Accurate Statements
Cigarette smoking increases risk of serious cardiovascular events with COC use.
Boxed Warning excerpt: “Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use.”
Women over 35 years of age who smoke should not use COCs.
Boxed Warning excerpt: “For this reason, COCs should not be used by women who are over 35 years of age and smoke”; also Contraindications: “Smoke, if over age 35”; and Patient Counseling: “women who are over 35 years old and smoke should not use COCs.”
Unsupported Statements
The claim is phrased as a strict contraindication: “contraindicated if over age 35 and smoking.”
While the label provides both contraindications language (“Smoke, if over age 35”) and boxed warning language (“should not be used”), the provided evaluation/citations do not clearly demonstrate that the label uses the exact term and phrasing 'contraindicated if over age 35 and smoking' as written.
Contradictions
Important Omissions
Safety Assessment
Potential Patient Risk:
Low
The underlying safety message (smoking and age >35 with COCs) is aligned with the label’s boxed warning/contraindications concept; only the exact legal/wording framing ('contraindicated' vs 'should not be used') is partially mismatched.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Partially Aligned
Primary Issue
Imprecise regulatory wording: claim uses 'contraindicated' phrasing without clearly matching exact label wording as cited.
Suggested Improvement
Rephrase to match the label text precisely (e.g., “Beyaz should not be used by women over 35 who smoke” or “Beyaz is contraindicated with smoking if over age 35”), using the label’s own phrasing from the Contraindications and/or Boxed Warning sections.