What are the guidelines for prescribing Drospirenone (a progestin)-containing Oral Contraceptive Pills (OCPs), such as Yasmin (Drospirenone and Ethinyl Estradiol), to women at risk of Venous Thromboembolism (VTE)?

Guidelines for Prescribing Drospirenone-Containing OCPs in Women at Risk of VTE

Drospirenone-containing oral contraceptive pills (OCPs) should be avoided in women at risk of venous thromboembolism (VTE) due to a significantly higher VTE risk compared to levonorgestrel-containing OCPs. 1

Risk Assessment for VTE with Drospirenone-Containing OCPs

Drospirenone-containing OCPs carry a higher risk of VTE compared to other progestins:

• Baseline risk of VTE in non-users: 1-5 per 10,000 woman-years
• Risk with standard OCPs: 3-9 per 10,000 woman-years
• Risk with drospirenone-containing OCPs: approximately 10 per 10,000 woman-years 2
• FDA-sponsored studies show drospirenone carries a 1.5-1.8 times higher risk compared to levonorgestrel-containing OCPs 1

Absolute Contraindications for Drospirenone-Containing OCPs

Drospirenone-containing OCPs are absolutely contraindicated in women with:

• History of VTE or current VTE 1
• Cerebrovascular disease 1
• Coronary artery disease 1
• Thrombogenic valvular or rhythm heart diseases 1
• Inherited or acquired hypercoagulopathies 1
• Uncontrolled hypertension 1
• Diabetes with vascular disease 1
• Migraine with aura (at any age) or without aura if over age 35 1
• Smoking in women ≥35 years (especially ≥15 cigarettes/day) 2, 1
• Renal impairment 1
• Adrenal insufficiency 1

Risk Stratification Algorithm for Drospirenone-Containing OCPs

1. High Risk (Category 4 - Do NOT use drospirenone-containing OCPs):

   • Any absolute contraindication listed above
   • Multiple risk factors for VTE
   • Postpartum <21 days (breastfeeding) 2
   • Postpartum <21 days (non-breastfeeding) 2

2. Moderate-High Risk (Category 3 - Avoid drospirenone, use alternative methods):

   • Age ≥35 years with smoking <15 cigarettes/day 2
   • BMI ≥30 kg/m² 2
   • Postpartum 21-42 days with other VTE risk factors 2
   • Family history of VTE in first-degree relative
   • Major surgery with prolonged immobilization 2

3. Low-Moderate Risk (Category 2 - Consider alternatives first):

   • Age <35 years with smoking 2
   • Obesity without other risk factors

Alternative Contraceptive Options for Women at Risk of VTE

For women at increased risk of VTE, consider these alternatives in order of preference:

1. Non-hormonal methods:

   • Copper IUD (Category 1 for most VTE risk factors) 2
   • Barrier methods

2. Progestin-only methods:

   • Levonorgestrel IUD (Category 1 for most VTE risk factors) 2
   • Implant (Category 1 for most VTE risk factors) 2
   • Progestin-only pills (Category 1-2 for most VTE risk factors) 2

Important Clinical Considerations

• When prescribing OCPs solely for acne treatment, the VTE risk of drospirenone must be weighed against the lower risks of acne itself 2
• The risk of VTE is highest in the first year of OCP use 3
• For women with no VTE risk factors who strongly prefer drospirenone for non-contraceptive benefits (such as acne treatment), ensure thorough counseling about the comparative VTE risk
• The absolute risk of VTE with drospirenone remains lower than the VTE risk during pregnancy (5-20 per 10,000 woman-years) and postpartum (40-65 per 10,000 woman-years) 2

Monitoring Recommendations

• Monitor for signs and symptoms of VTE (leg pain/swelling, chest pain, shortness of breath)
• Educate patients about warning signs requiring immediate medical attention
• Consider discontinuation before major surgery or during prolonged immobilization

By following these guidelines, clinicians can make informed decisions about prescribing drospirenone-containing OCPs while minimizing the risk of VTE in susceptible women.