Excellent
Fully Aligned
Patient Risk:
Low
Summary
The claim exactly matches the provided FDA-approved Vienva labeling language stating oral contraceptives do not protect against transmission of HIV/AIDS and listed STDs.
Category Scores
Accurate Statements
Oral contraceptives (Vienva) do not protect against transmission of HIV/AIDS and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
Supported by provided label excerpts: (1) 5 PRECAUTIONS: “Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.” (2) DETAILED PATIENT LABELING: “Oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.”
Unsupported Statements
Contradictions
Important Omissions
None material for evaluating this specific claim (lack of protection against HIV/AIDS and listed STDs).
Importance:
Low
Safety Assessment
Potential Patient Risk:
Low
The claim is an exact match to on-label patient counseling language regarding lack of protection against HIV/AIDS and other STDs.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Fully Aligned
Primary Issue
Suggested Improvement