EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC) recent review revealed negative mental health impact of finasteride and dutasteride on patients taking it for anti-hair loss purposes.
Finasteride (1 mg tablets or skin sprays) is approved in several EU countries to treat early-stage male pattern baldness in men aged 18 to 41. Both finasteride and dutasteride reduce levels of DHT a hormone linked to hair loss and prostate enlargement by blocking the 5-alpha reductase enzyme. This helps slow hair loss, promote hair growth, and shrink the prostate.
Finasteride 1mg & 5mg has shown multiple suicidal ideation cases, hence patients are advised to report to a health care professional if they experience any sudden mood changes like depression, decreased sex drive & Suicidal thoughts.
While no direct link was found between dutasteride and suicidal thoughts, mood-related warnings from finasteride will be added to dutasteride as a precaution. No changes are needed for finasteride skin sprays, as no risk was identified.
To reach its conclusion, the PRAC reviewed data on the safety and effectiveness of finasteride and dutasteride, including clinical trials, scientific studies, and reports from EudraVigilance. Out of an estimated 270 million patient years for finasteride and 82 million for dutasteride, 325 cases of suicidal thoughts were identified mostly in patients using finasteride for hair loss. These cases were considered possibly or probably linked to the treatment.
Ultimately, it is the responsibility of healthcare professionals to counsel patients on potential side effects and advise them to discontinue treatment and seek medical attention if they experience sudden mood changes or sexual dysfunction.
