The European Medicines Agency (EU) has confirmed that patients taking the drug finasteride for hair loss may experience suicidal thoughts. This announcement follows a wide review across the EU and will prompt new warnings to users and prescribers.
Finasteride is often used in 1mg dosage to treat male pattern baldness and in higher doses for prostate enlargement. Until now, mood changes were already listed among its side effects, but the new review now recognises that suicidal ideation must be included as a potential risk.
The review could not establish how common suicidal thoughts are in users, because of limitations in available data. Most reports came from people using the 1mg form for hair loss rather than higher doses.
Under the new measures, packages of finasteride 1mg will include patient cards advising of mood risks. In addition, Dutasteride (a related drug) is being updated in its product information to carry similar warnings, even though a direct link was not confirmed in the review.
This development arrives at a time when concerns about long term safety monitoring of psychiatric and neurological risks tied to drugs are mounting. A recent Swedish study found that use of psychiatric medications such as antidepressants, anxiolytics, hypnotics or sedatives was associated with a modest increase in risk of developing amyotrophic lateral sclerosis (ALS) and with faster decline after diagnosis.
Another recent UK report shows that people who have used antidepressants for a long duration report more severe withdrawal symptoms when they stop the medication.
In this context, a pharmacovigilance scientist commenting on the finasteride decision might emphasise how difficult it can be to detect rare psychiatric signals before a drug is on the market. She could point out the importance of ongoing adverse event reporting systems, robust risk management plans, and transparent updates to drug labels when new evidence emerges.
This is not just about labelling or regulation. For millions using medications daily, assurance of safety is essential. When unexpected side effects emerge, patient trust can be shaken. Proper vigilance helps ensure that benefits remain greater than harms.