Taiwan’s Food and Drug Administration (TFDA) announced that medications containing hydroxyprogesterone caproate will have their licenses revoked by January 2026, following a re-evaluation of their clinical benefits and risks. These drugs are commonly prescribed for gynecological conditions such as dysmenorrhea, irregular menstruation, and recurrent miscarriage. Starting next January, patients and healthcare providers will need to switch to alternative treatments.

Chi Jo-Feng, researcher at the TFDA's Drug Division, explained that hydroxyprogesterone caproate—also known as 17-OHPC or OHPC—is a synthetic long-acting progestin. It is typically used to manage issues such as difficult menstruation, uterine bleeding, and habitual miscarriage.

TFDA data shows that over the past two years, about 400,000 doses of such drugs were purchased out-of-pocket, while approximately 200 doses per year were covered by the National Health Insurance, which maintains strict reimbursement criteria. There are currently 16 approved alternative medications, including four oral formulations, four vaginal suppositories, and eight injectable products. Following this announcement, the TFDA will notify relevant medical associations so physicians can determine suitable alternatives for patients.

The decision to revoke licenses is based on several concerns: epidemiological studies have suggested that early pregnancy exposure to hydroxyprogesterone caproate may increase the risk of cancer in male offspring. Furthermore, the drug has shown no proven benefit in preventing preterm birth. Regulatory agencies in the United States, Canada, and Australia have already withdrawn approval for this ingredient. The European Union, after conducting a comprehensive risk-benefit review, suspended its sale in June 2024. Japan still permits its use but requires drug labels to clearly state it is strictly contraindicated for women who are pregnant or may become pregnant.

In Taiwan, three products containing this ingredient are currently licensed: Capron Injection, Taiyu Hydroxyprogesterone Injection, and Proluton Depot. These drugs are primarily used to treat conditions such as recurrent miscarriage, dysmenorrhea, and amenorrhea. After the licenses are revoked, patients and healthcare providers must switch to alternative progestin-based treatments, including oral, vaginal, and water-based injectable options.

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