The European Medicines Agency (EMA) has confirmed that finasteride, a widely prescribed medication for male pattern hair loss, carries a rare risk of suicidal thoughts following an EU-wide review of available data.
Findings from the Safety Review
The EMA's safety committee examined 313 reports of suicidal ideation among patients taking finasteride, which is prescribed in 1mg tablets under brand names such as Propecia for men aged 18 to 41 experiencing hair loss. The medication is also available in 5mg doses for treating benign prostatic hyperplasia (BPH), a condition causing prostate enlargement and urinary problems.
According to the regulator, most cases of suicidal thoughts were reported in individuals using the 1mg formulation specifically marketed for hair loss treatment. However, the EMA noted that "the frequency of the side effect is unknown" based on the available data.
"While psychiatric side effects including depression were already listed in the product information, this comprehensive review provides stronger evidence for the specific risk of suicidal ideation," the safety committee stated in its findings.
New Safety Measures Implemented
Despite these concerns, the EMA has determined that finasteride's benefits continue to outweigh its risks for all approved uses. The medication will remain available, but with enhanced safety measures:
- A patient card will now be included in packages of 1mg finasteride tablets
- The card will remind patients about the risk of suicidal thoughts and other mood changes
- Guidance on appropriate actions if side effects occur will be provided
- Patients experiencing mood changes while taking finasteride are advised to discontinue the medication and seek medical advice immediately
Broader Implications for Related Medications
In a precautionary move, the EMA is also extending similar warnings to dutasteride, another medication primarily used to treat prostate enlargement. Although the safety committee found insufficient evidence directly linking dutasteride to suicidal ideation, the warning is being added because both medications work through similar mechanisms.
"Given that dutasteride operates through the same pharmacological pathway as finasteride, we're taking a cautious approach by including these warnings," explained the EMA in its statement.
Context and Prevalence
The agency emphasized the relative rarity of these adverse events, noting that the reported cases represent only a small fraction of the total patient population. According to the EMA, there were "only a few hundred reports of suicidal ideation among about 270 million patients taking finasteride and 82 million taking dutasteride."
Both medications function by inhibiting the enzyme 5-alpha reductase, which converts testosterone to dihydrotestosterone (DHT), a hormone linked to hair loss in men with genetic predisposition and prostate enlargement.
Other Known Side Effects
Finasteride has previously been associated with other side effects, including:
- Decreased libido
- Erectile dysfunction
- Ejaculation disorders
- Breast tenderness and enlargement
Some patients have reported persistence of sexual side effects even after discontinuing the medication, though this remains an area of ongoing research.
Expert Recommendations
Healthcare professionals are advised to inform patients about the potential psychiatric risks associated with finasteride and to monitor for signs of mood changes, depression, or suicidal thoughts during treatment.
"The benefit-risk profile remains positive, but proper patient education and monitoring are essential," the EMA concluded. "Patients should be encouraged to report any mood changes promptly to their healthcare provider."
