The Short Answer: Is dydrogesterone available in the US?
No, the synthetic progestin dydrogesterone is not currently available for prescription or sale in the United States. The medication, once marketed under the brand names Duphaston and Gynorest, was voluntarily pulled from the US market by its manufacturer decades ago. This was a commercial decision, not one based on safety or effectiveness concerns. For patients moving to the US or traveling from countries where it is used, it is crucial to understand its unavailable status and discuss appropriate, FDA-approved alternatives with a local healthcare provider.
Why was dydrogesterone withdrawn from the US market?
The withdrawal of dydrogesterone from the American market is not due to a ban or any FDA-mandated safety recall. Instead, it was a business-driven decision. The US license for dydrogesterone was held by Solvay Pharmaceuticals, which withdrew the product in 1997 because the approved indications were no longer considered commercially viable. In 2017, the FDA formally addressed a citizen's petition by confirming that Gynorest (dydrogesterone) was not withdrawn for reasons of safety or effectiveness. This determination confirms its benign regulatory status but does not change its unavailability to patients.
Dydrogesterone's Global Use and Indications
In contrast to its status in the US, dydrogesterone remains a widely used and well-regarded medication in many other parts of the world, including Europe, Asia, and Australia. It is often prescribed for a range of women's health issues, taking advantage of its favorable pharmacological profile, which includes a high oral bioavailability and selective progesterone receptor agonism.
Common indications for dydrogesterone internationally include:
- Treatment of endometriosis: Dydrogesterone can help alleviate the painful symptoms of endometriosis and inhibit the growth of ectopic endometrial tissue.
- Luteal phase support: It is frequently used to support the luteal phase in assisted reproductive technology (ART) treatments like IVF to aid with embryo implantation and pregnancy maintenance.
- Management of menstrual disorders: This includes treating dysfunctional uterine bleeding, irregular cycles, and premenstrual syndrome (PMS).
- Threatened or recurrent miscarriage: Some guidelines support its use in early pregnancy to help prevent miscarriage in cases of progesterone insufficiency.
- Hormone replacement therapy (HRT): It is combined with estrogen in certain formulations for postmenopausal women.
FDA-Approved Progestin Alternatives in the US
For those in the US who require progesterone therapy, several FDA-approved alternatives can serve the same therapeutic purposes as dydrogesterone. It is important to note that while these medications are functionally similar, they are not identical and may differ in bioavailability, route of administration, and side effect profile. A consultation with a healthcare provider is essential to determine the most appropriate alternative.
Oral progesterone and progestin options include:
- Micronized Progesterone: Available under the brand name Prometrium, this oral formulation is chemically identical to the progesterone produced naturally in the body. It is used in HRT and for certain menstrual disorders.
- Medroxyprogesterone Acetate (MPA): Commonly known as Provera, this is a synthetic progestin used for menstrual disorders and to prevent endometrial hyperplasia in HRT.
Vaginal progesterone options for reproductive health:
- Progesterone Vaginal Inserts: Brand names like Endometrin provide direct uterine delivery for luteal phase support during IVF.
- Progesterone Vaginal Gel: Crinone is a vaginal gel also used for luteal phase support in assisted reproduction.
Comparison of Dydrogesterone vs. US Progestin Alternatives
| Feature | Dydrogesterone | Micronized Progesterone (e.g., Prometrium) | MPA (e.g., Provera) | Vaginal Progesterone (e.g., Endometrin) |
|---|---|---|---|---|
| US Status | Not Available | Available (Oral) | Available (Oral) | Available (Vaginal) |
| Availability | >100 countries globally, not US | Widely available in the US | Widely available in the US | Widely available in the US |
| Indications | Endometriosis, infertility, menstrual disorders, HRT | HRT, menstrual disorders | Menstrual disorders, HRT | Luteal phase support (IVF) |
| Route | Oral Tablet | Oral Capsule | Oral Tablet | Vaginal Insert/Gel |
| Form | Synthetic Progestin | Bioidentical Progesterone | Synthetic Progestin | Bioidentical Progesterone |
| Bioavailability | High Oral | Variable Oral, subject to first-pass metabolism | High Oral | Targeted Uterine Delivery |
| Reason for Non-Availability | Commercial withdrawal, not safety | N/A | N/A | N/A |
Conclusion: Navigating Hormonal Treatments in the US
For patients and healthcare providers in the US, it is important to be aware that dydrogesterone is not a treatment option, despite its widespread use internationally. The decision to withdraw it was based on commercial viability and was not related to safety or effectiveness. Fortunately, a range of safe and effective FDA-approved alternatives are available to address the same conditions for which dydrogesterone is prescribed elsewhere. By consulting with a healthcare professional, individuals can receive appropriate guidance and access the best treatment plan using available US options. Patients should rely on medical advice and refrain from attempting to import medications for which domestic alternatives exist.
For more information on the FDA's determination regarding dydrogesterone's withdrawal, see the official announcement in the Federal Register: Determination That GYNOREST (Dydrogesterone) Oral Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness.
