Is Annovera (segesterone acetate and ethinyl estradiol) safe for use in women over 35?

Safety of Annovera After Age 35

Annovera (segesterone acetate and ethinyl estradiol vaginal ring) is contraindicated in women over 35 years of age who smoke, and should be used with caution in non-smoking women over 35 due to increased cardiovascular risks.

Contraindications for Annovera in Women Over 35

Annovera, like other combined hormonal contraceptives (CHCs), carries specific contraindications for women over 35 years of age:

• Absolute contraindications:
  • Women over 35 who smoke (≥15 cigarettes daily) 1
  • History of venous thromboembolism (VTE), stroke, or cardiovascular disease 2, 1
  • Migraine headaches with aura (at any age) or without aura (if over 35) 1
  • Uncontrolled hypertension or hypertension with vascular disease 1
  • Diabetes with vascular complications or duration >20 years 1
  • Multiple risk factors for atherosclerotic disease 2, 1

Cardiovascular Risk Considerations

The FDA label for Annovera specifically warns about increased cardiovascular risks:

1. Venous Thromboembolism (VTE):

   • Risk of VTE in CHC users is estimated at 3-12 cases per 10,000 woman-years 1
   • Risk is highest during the first year of use and when restarting after a break 1

2. Age-related cardiovascular risks:

   • The risk for cardiovascular disease increases with age 1
   • Certain conditions that don't contraindicate CHC use in younger women become contraindications after age 35 1

3. Risk factors requiring careful assessment:

   • Hypertension
   • Diabetes
   • Dyslipidemia
   • Obesity 1

Safety Profile Compared to Other Contraceptives

For women over 35 who don't smoke and have no other contraindications:

• The safety profile of Annovera is generally similar to other combined hormonal contraceptives 3, 4
• However, there have been reports of venous thromboembolism occurring more frequently than expected with Annovera, leading the FDA to require a postmarketing study 5

Alternative Contraceptive Options for Women Over 35

For women over 35 with contraindications to Annovera, safer alternatives include:

1. Progestin-only methods:

   • Progestin-only pills
   • Progestin implants
   • Progestin IUDs 6

2. Non-hormonal methods:

   • Copper IUD
   • Barrier methods 6

3. For breast cancer risk reduction in high-risk women over 35:

   • Tamoxifen, raloxifene, exemestane, or anastrozole may be considered 6

Monitoring Recommendations

If Annovera is used in eligible women over 35 who don't smoke and have no contraindications:

• Regular blood pressure monitoring 2
• Assessment for signs/symptoms of VTE, stroke, or cardiovascular disease 1
• Immediate medical attention for warning signs: severe abdominal pain, chest pain, shortness of breath, severe headache, vision changes, or severe leg pain/swelling 2

Key Takeaways

1. Annovera is absolutely contraindicated in women over 35 who smoke.

2. For non-smoking women over 35, a thorough cardiovascular risk assessment is essential before prescribing Annovera.

3. Alternative contraceptive methods should be considered for women over 35 with any cardiovascular risk factors.

4. The decision to use Annovera in women over 35 should carefully weigh the increased risks against the benefits, with progestin-only or non-hormonal methods generally being safer options.