Excellent
Fully Aligned
Patient Risk:
Low
Summary
The claim accurately reflects the supplied FDA label text on increased cardiovascular/cerebrovascular risk from smoking with oral contraceptives, including heightened risk in women >35 and the counseling that women using oral contraceptives should not smoke.
Category Scores
Accurate Statements
Smoking in combination with Femcon Fe use increases cardiovascular/heart & blood vessel risk.
Supported by 5. WARNINGS (myocardial infarction incidence/mortality in smokers) and 5. WARNINGS (increased cerebrovascular events/stroke risk in users who smoke).
Smokers (especially over 35) are at substantially higher risk.
Supported by 5. WARNINGS (greatest/mid-thirties or older; mortality substantially increases over age 35) and continued warnings (risk greatest among older (>35) women who also smoke).
Women using oral contraceptives should not smoke.
Supported by DETAILED PATIENT PACKAGE INSERT: “Women who use oral contraceptives should not smoke.”
Unsupported Statements
Contradictions
Important Omissions
Safety Assessment
Potential Patient Risk:
Low
The statement reflects on-label risk counseling and does not introduce unsupported or conflicting guidance. No omitted safety elements were identified as material for this specific claim.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Fully Aligned
Primary Issue
Suggested Improvement