Poor
Not Aligned
Patient Risk:
High
Summary
Only the general indication and the core cyclic regimen (21 days in, 7 days out; 13 cycles/year) are supported by the provided label excerpts. Many detailed administration/troubleshooting statements (including expulsion time-window and backup contraception duration; tampon/sex-expulsion guidance; multiple insertion/removal techniques) are not supported by the supplied label sections, and several safety-critical label areas (boxed warning/contraindications/use in specific populations) were not assessed.
Category Scores
Accurate Statements
Annovera prevents pregnancy.
Supported by 1 INDICATIONS AND USAGE.
Annovera provides contraceptive effect for a full year (13 cycles) with monthly use.
Supported by 2.1 How to Use ANNOVERA (one vaginal system provides contraception for 13 cycles).
Annovera is left in for 21 days per cycle.
Supported by 2.1 How to Use ANNOVERA (remain in the vagina continuously for 21 days/3 complete weeks).
Annovera is removed after 21 days.
Supported by 2.1 How to Use ANNOVERA (removed for a 1-week dose-free interval).
The next cycle is started after 7 ring-free days.
Supported by 2.1 How to Use ANNOVERA (removed for a 1-week dose-free interval; then cleaned prior to being placed back for another 21 continuous days).
Unsupported Statements
Annovera is a reusable vaginal ring contraceptive made by TherapeuticsMD.
No manufacturer/reusability attribution supported by the provided label excerpts.
Annovera releases segesterone acetate and ethinyl estradiol.
No hormone composition/release statement present in the provided label excerpts.
After removal, the ring is placed in the provided case for up to 2 months.
Provided label excerpt supports placing in its case during the 1-week dose-free interval, but does not support an 'up to 2 months' duration.
Rings can slip out during sex, bowel movements, or tampon use.
Not supported by any provided label excerpt.
Tampons should be avoided with Annovera.
Not supported by any provided label excerpt.
If expulsion is noticed within 3 hours, the ring should be rinsed with cool water and reinserted.
Not supported by any provided label excerpt.
If the ring has been out for longer than 3 hours, backup contraception should be used for 7 days.
Not supported by any provided label excerpt.
If pain or discomfort occurs, the ring should be removed, checked for damage, and reinserted or the patient should contact a doctor.
Not supported by any provided label excerpt.
The ring should not be forced if insertion/removal is difficult.
Not supported by any provided label excerpt.
If the ring cannot be reached, lying down and bearing down like during a bowel movement may help with reaching it using a finger.
Not supported by any provided label excerpt.
The ring should be discarded after 13 cycles.
The excerpt supports that one vaginal system provides contraception for 13 cycles, but does not explicitly state disposal wording/rule; thus 'should be discarded after 13 cycles' is not fully supported by the provided excerpt.
Partners rarely feel the ring during sex.
Not supported by any provided label excerpt.
If the ring is inserted too shallow, it can cause discomfort or expulsion.
Not supported by any provided label excerpt.
Handwashing before insertion reduces infection risk.
Not supported by any provided label excerpt (even though the label mentions 'With clean hands' for insertion position).
The ring should not be used if it is torn or sticky.
Not supported by any provided label excerpt.
The ring should be checked daily by touch during the first week of each cycle.
Not supported by any provided label excerpt.
Contradictions
Important Omissions
No assessment/coverage of contraindications (Section 4), boxed warning/major warnings and precautions (Section 5/Box), drug interaction details (Section 7), and use in specific populations including pregnancy (Section 8) in relation to the counseling/administration claims provided.
Importance:
High
Missed/expelled ring guidance is only partially reflected: the provided label excerpt contains deviation guidance based on time out of vagina relative to 7 days in a 28-day cycle, but the AI response provided specific 3-hour thresholds and backup contraception details without label support.
Importance:
High
Safety Assessment
Potential Patient Risk:
High
Multiple detailed administration/troubleshooting statements that affect contraceptive effectiveness (expulsion time windows; backup contraception duration; tampon/sex-related expulsion counseling) are not supported by the provided label excerpts, and major safety sections (contraindications/warnings/pregnancy) were not evaluated.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Not Aligned
Primary Issue
Many administration and troubleshooting claims (including 3-hour/7-day expulsion/backup guidance and tampon/sex slip counseling) are not supported by the supplied label excerpts.
Suggested Improvement
Restrict claims to information explicitly supported by the FDA label excerpts provided (e.g., 21 days in/1-week dose-free interval; cleaning in case during the 1-week interval; 13 cycles per system) and, for expulsion/missed-use counseling, align precisely with the label’s deviation guidance (7-day/28-day cycle framing) or cite the specific Patient Information/Instructions for Use sections where those time thresholds are specified.