Drospirenone Availability in the United States
Yes, drospirenone is available in the United States in multiple FDA-approved formulations, both as combined oral contraceptives and as a progestin-only pill. 1, 2
Available Formulations
Combined Oral Contraceptives (COCs)
- Drospirenone 3 mg/ethinyl estradiol 0.03 mg (Yasmin): 21/7 day regimen (21 active pills, 7 inactive) 3, 4
- Drospirenone 3 mg/ethinyl estradiol 0.02 mg (Yaz): 24/4 day regimen (24 active pills, 4 inactive) 5, 2, 6
- Drospirenone 3 mg/ethinyl estradiol 0.02 mg/levomefolate (Beyaz): Contains added folate 7
- Estetrol 15 mg/drospirenone 3 mg: Newest formulation combining natural estrogen with drospirenone 1, 8
Generic Availability
- All drospirenone-containing COCs are currently available in generic forms in the US 1
FDA-Approved Indications
Drospirenone-containing contraceptives have received FDA approval for multiple indications beyond contraception 2, 9:
- Contraception (pregnancy prevention) 2, 6
- Premenstrual dysphoric disorder (PMDD) treatment in women who desire oral contraception 2, 9
- Moderate acne vulgaris treatment in women ≥14 years old who have achieved menarche and desire oral contraception 1, 2
Unique Properties of Drospirenone
Pharmacologic Characteristics
- Drospirenone is a fourth-generation progestin and spironolactone analogue with antimineralocorticoid and antiandrogenic properties 1, 10
- Unlike other synthetic progestins, drospirenone is not derived from testosterone, which contributes to its antiandrogenic effects 1
- Has a half-life exceeding 30 hours, allowing extended activity into the hormone-free interval 3
Blood Pressure Effects
- Drospirenone may decrease blood pressure due to its antimineralocorticoid properties, unlike other progestins that may elevate blood pressure 1, 5
- Studies demonstrate systolic blood pressure reductions of 1-4 mmHg when combined with ethinyl estradiol 1
- As a progestin-only pill (4 mg dose), drospirenone decreases systolic blood pressure by 8 mmHg in patients with elevated baseline blood pressure 1, 5
Important Safety Considerations
Contraindications
Drospirenone-containing products are contraindicated in patients with 2:
- Renal impairment (due to potassium-sparing effects)
- Adrenal insufficiency
- Standard COC contraindications: history of venous thromboembolism, uncontrolled hypertension, smoking over age 35, coronary artery disease, cerebrovascular disease, breast cancer, liver disease
Venous Thromboembolism Risk
- Drospirenone-containing COCs may carry a higher VTE risk compared to levonorgestrel-containing pills 1, 7
- Estimated VTE incidence: 10 per 10,000 person-years for drospirenone-containing COCs versus 3-9 per 10,000 for other COCs 1
- The hazard ratio for VTE with drospirenone versus levonorgestrel is 1.77 (95% CI 1.33-2.35) 8
Hyperkalemia Monitoring
- Drospirenone has potassium-sparing effects due to antimineralocorticoid activity 2
- Patients must inform providers if taking: NSAIDs, potassium-sparing diuretics, potassium supplements, ACE inhibitors, angiotensin-II receptor antagonists, heparin, aldosterone antagonists, or strong CYP3A4 inhibitors 2
- Large noninterventional studies have not shown increased hyperkalemia risk compared to other COCs in routine use 3