Brussels, May 8 — The European Medicines Agency (EMA) has confirmed that suicidal thoughts are a potential side effect of the hair loss medication finasteride, following a comprehensive review of safety data across the European Union.
The confirmation comes from the agency’s Pharmacovigilance Risk Assessment Committee (PRAC), which found that most reported cases of suicidal ideation involved patients taking the 1 mg dose of finasteride. This dosage is commonly prescribed to treat androgenetic alopecia, a hormone-related form of hair loss.
While the EMA acknowledged the presence of suicidal thoughts among users, it noted that the frequency of the side effect could not be determined from the currently available data.
The review, initiated in October 2023, also evaluated dutasteride—another medication used for hair loss and prostate issues—but did not find sufficient evidence to establish a similar link with suicidal ideation. As a precautionary measure, however, information regarding mood changes will be added to dutasteride’s product documentation.
Finasteride is marketed under the brand name Propecia by U.S.-based pharmaceutical company Organon (OGN.N), while British drugmaker GSK (GSK.L) sells dutasteride under the brand name Avodart. Generic versions of both medications are widely available. Neither Organon nor GSK have responded publicly to the EMA’s findings as of the time of reporting.
Both drugs are also prescribed to treat benign prostatic hyperplasia, a non-cancerous enlargement of the prostate gland.
Despite the updated safety concerns, the EMA concluded that the overall benefits of finasteride and dutasteride continue to outweigh their risks for all approved uses. However, the agency recommended that suicidal ideation be officially listed as a side effect on packaging for finasteride tablets.
To enhance patient awareness, a warning card will be included in finasteride 1 mg tablet packages, alerting users to potential psychiatric side effects and advising them on appropriate steps should symptoms arise.
Related Topics:
- Peppermint Oil for Hair Growth: Hype or Hope? What Science Says
- Kaya Clinics Launch Pioneering Cell-Based Hair Fall Treatment in India
- Dermatologist Emphasizes the Importance of Scalp Care in Skincare Routine
