Partial
Partially Aligned
Patient Risk:
Moderate
Summary
The provided label excerpts support the general contraceptive indication for pregnancy prevention and do not address STI protection; however, multiple claims about STI non-protection and condom necessity/protective effects are not supported or contradicted by the supplied label text.
Category Scores
Accurate Statements
Annovera is hormonal contraception.
Label excerpt does not explicitly use the phrase “hormonal contraception,” but ANOVERA contains segesterone acetate and ethinyl estradiol and is indicated to prevent pregnancy (Section 1).
Annovera prevents pregnancy by releasing hormones.
Supported in substance by the indication: “ANNOVERA is indicated… to prevent pregnancy.” (Section 1). Mechanism wording (“releasing hormones”) is not quoted in provided label text.
Unsupported Statements
Annovera does not stop sexually transmitted infections (STIs).
No supplied label section addresses STI prevention/does not address protection against STIs.
Using Annovera does not protect against HIV.
No supplied label section addresses HIV prevention/protection.
Using Annovera does not protect against chlamydia.
No supplied label section addresses chlamydia prevention/protection.
Using Annovera does not protect against gonorrhea.
No supplied label section addresses gonorrhea prevention/protection.
Using Annovera does not protect against syphilis.
No supplied label section addresses syphilis prevention/protection.
Using Annovera does not protect against herpes.
No supplied label section addresses herpes prevention/protection.
Using Annovera does not protect against HPV.
No supplied label section addresses HPV prevention/protection.
For STI protection, barrier protection such as condoms is needed.
No supplied label section addresses need for condoms/barrier methods for STI prevention.
Condons reduce the risk of many STIs when used correctly every time you have sex.
No supplied label section addresses effect of condoms on STI risk.
Condom use reduces STI risk even if you also use Annovera for pregnancy prevention.
No supplied label section addresses condoms in combination with Annovera for STI risk.
Testing can reduce uncertainty but does not eliminate risk for every STI or for future exposures.
No supplied label section addresses STI testing reducing uncertainty or residual risk.
Since Annovera does not provide STI protection, safer-sex practices (especially condoms) are the main way to reduce STI risk.
No supplied label section supports the premise about Annovera lacking STI protection or endorses “main way” phrasing.
Contradictions
Important Omissions
Clarification of Annovera’s approved limitations and/or usage instructions related to pregnancy prevention (beyond the provided label excerpt).
Importance:
Moderate
When evaluating contraception vs. STI prevention, the label excerpts provided do not include the relevant “Limitations of Use” language about STI protection (if present in the full label).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Statements regarding lack of STI protection and reliance on condoms/safe-sex practices are not supported by the supplied label excerpts; unsupported guidance could mislead about STI risk mitigation if inaccurate relative to the full FDA label.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Multiple STI/HIV/STD protection claims (including condom effectiveness guidance) are not supported by the provided FDA label excerpts.
Suggested Improvement
Limit claims to the label-supported indication (pregnancy prevention) and avoid asserting STI/HIV protection or condom risk-reduction effectiveness unless that information is explicitly present in the supplied prescribing information.