What are the safety concerns with using Yaz (drospirenone and ethinyl estradiol) for birth control?

Safety Concerns with Yaz (Drospirenone and Ethinyl Estradiol) for Birth Control

Yaz carries a higher risk of venous thromboembolism compared to other combined oral contraceptives, with approximately 9 per 10,000 person-years for drospirenone-containing pills versus 6 per 10,000 person-years for other COCs. 1

Thrombotic Risk

Drospirenone-containing combined oral contraceptives (COCs) like Yaz have specific safety concerns that differentiate them from other birth control options:

• Venous thromboembolism (VTE): The risk is approximately 9 per 10,000 person-years for drospirenone-containing COCs compared to approximately 6 per 10,000 person-years for other COCs 1
• Due to these risks, the FDA labeling for drospirenone-containing COCs includes a warning to limit use to those who also desire contraception 1
• Important context: The risk of VTE is still higher with pregnancy (approximately 197-776 per 10,000 women-years) than with any hormonal contraceptive 1, 2

Absolute Contraindications

Yaz should not be used in women with:

• History of or current venous thromboembolism 1
• Known thrombogenic mutations (factor V Leiden, prothrombin mutation, etc.) 1
• Multiple risk factors for arterial cardiovascular disease 1
• Current or history of ischemic heart disease 1
• Current or history of stroke 1
• Complicated valvular heart disease 1
• Migraine with aura 1
• Current breast cancer 1
• Systemic lupus erythematosus with positive antiphospholipid antibodies 1, 2

Other Safety Concerns

• Hyperkalemia risk: Drospirenone has antimineralocorticoid properties similar to spironolactone 3, 4

  • However, multiple large retrospective cohort studies have found no increased risk of hyperkalemia compared to other COCs 1
  • Even concomitant use with spironolactone showed no significant increased risk for hyperkalemia 1

• Common side effects include:

  • Breakthrough bleeding (especially in first 2-3 cycles) 1
  • Nausea and breast tenderness 1
  • These side effects typically resolve within the first 2-3 cycles of use 1

Potential Benefits

Despite these risks, Yaz offers some unique benefits:

• The drospirenone component has antimineralocorticoid activity that may prevent water retention and weight gain often associated with other COCs 5, 3
• It has antiandrogenic properties that can improve acne and other androgen-related conditions 5, 4
• FDA-approved for treatment of premenstrual dysphoric disorder (PMDD) and moderate acne in women who desire contraception 3, 4

Monitoring Recommendations

• Regular follow-up is necessary to assess for any complications
• Women with risk factors for VTE should be monitored closely
• No special potassium monitoring is required in healthy women without risk factors for hyperkalemia 1

Practical Considerations

• Effectiveness: Approximately 9 out of 100 women become pregnant in the first year with typical use of combined hormonal contraceptives 1
• A course of three to six months is typically required for patients to experience the full benefit of treatment with a COC 1
• When starting Yaz, if initiated within the first 5 days of menstrual bleeding, no additional contraceptive protection is needed 1
• If started >5 days since menstrual bleeding began, additional contraceptive protection is needed for 7 days 1

While Yaz is an effective contraceptive with some unique benefits, the increased thrombotic risk compared to other COCs means it should be prescribed with careful consideration of individual risk factors for thromboembolism.