An EU-wide review by the EMA’s safety committee (PRAC) has confirmed a potential link between finasteride and dutasteride medicines and suicidal ideation. While the benefits of these medications are deemed to outweigh the risks for approved uses, the product information will include warnings about mood changes, including depression and suicidal thoughts. The frequency of this side effect is currently unknown.

Most reported cases of suicidal ideation occurred in individuals using 1 mg finasteride for hair loss. The product information for finasteride 1 mg will now advise patients to seek medical help if they experience sexual dysfunction, as it may contribute to mood alterations and suicidal thoughts. A patient card will be included in the packaging to emphasize these risks and appropriate actions.

Although a direct link between dutasteride and suicidal ideation was not established, similar warnings about mood changes will be added to its product information as a precaution, given its similar mechanism of action to finasteride. The review did not find a connection between suicidal ideation and finasteride skin sprays, so no changes will be made to their product information.

Finasteride 1 mg tablets and skin spray treat early hair loss, while finasteride 5 mg tablets and dutasteride 0.5 mg capsules treat benign prostatic hyperplasia. More details can be found in the EMA’s public health communication.

Separately, the EMA’s safety committee (PRAC) has initiated a review of Ixchiq, a live attenuated chikungunya vaccine, due to reports of serious adverse events in elderly individuals. While the exact cause and relationship to the vaccine are still under investigation, many affected individuals had pre-existing conditions. To date, 17 serious adverse events have been reported worldwide in people aged 62 to 89 years who received the vaccine.

As a temporary measure, PRAC recommends that Ixchiq not be used in adults aged 65 years and above, pending the review's outcome. Ixchiq vaccination can continue in people under 65 years of age, following official guidelines. Healthcare professionals are also reminded not to administer Ixchiq to individuals with weakened immune systems due to the risk of complications from live attenuated vaccines.

Ixchiq is a single-dose vaccine authorized on June 28, 2024, used to protect against the mosquito-borne chikungunya virus, prevalent in tropical and subtropical regions. Symptoms of chikungunya include fever, joint pain, headache, muscle pain, joint swelling, and rash. While most patients recover within a week, some may experience prolonged joint pain, and a small percentage may develop severe acute disease. Approximately 43,400 doses have been used worldwide.

PRAC is reviewing all available data to assess the benefits and risks of Ixchiq, and EMA will provide further updates as necessary. More information is available in EMA’s public health communication, published on May 7, 2025.