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Sold for a long time under the name Propecia, finasteride, an anti-baldness drug, reportedly has serious side effects. The European Medicines Agency must currently reassess the benefit-risk balance of this treatment.
If you are taking finasteride to combat hair loss, this information concerns you. Thursday October 17, 2024, the National Medicines Safety Agency (ANSM) announced that the treatment must be re-evaluated by the pharmacovigilance committee of the European Medicines Agency (PRAC). In question? Its too many side effects.
A well-known treatment in men’s health
Sold for years under the name Propecia by the Dutch laboratory Organon, a former subsidiary of the American Merck (MSD), finasteride is one of the best-known treatments for hair loss in men. Finasteride 1 mg is indicated for the early stages of androgenic alopecia in men aged 18 to 41 years. Finasteride 5 mg as well as dutasteride 0.5 mg are also used in the treatment ofbenign prostatic hypertrophy and prevention of associated urological disorders.
However, the molecule has been the subject of much criticism for years for its side effects. Although propecia is no longer marketed, finasteride still exists in generic form, and remains widely used in France.
Suicidal thoughts among side effects
The ANSM is concerned: “These medications present risks of sexual dysfunction and psychiatric disorders which are described in the instructions and for which we maintain monitoring. The risks associated with finasteride 1mg are monitored even more closely as this medication is used in the early treatment of androgenetic hair loss, in young, healthy men.
These side effects are now documented. In fact, prevention actions have been regularly carried out since 2019, such as information campaigns, information on proper use or the importance of knowing how to report adverse effects. This no longer seems sufficient, according to the press release:
“Despite these actions, serious cases of psychiatric disorders and sexual disorders (which can sometimes persist long after treatment has stopped) continue to be reported to us. Additionally, suicidal ideation has recently been recognized as a potential adverse effect for two medications containing finasteride (Propecia 1 mg and Chibro-Proscar 5 mg). This request for re-evaluation is particularly important for finasteride 1 mg given its indication only in alopecia, a condition without health risks affecting young men.” indicates the ANSM.
The agency therefore requested a reassessment of the benefit-risk balance of finasteride and dutasteride, the latter belonging to the same pharmacological class as finasteride.
Consult a doctor online for your hair loss
What to do if you use finasteride treatment?
This request for re-evaluation goes hand in hand with further precautions requested from patients. If you are being treated with finasteride or dutasteride, and you suffer from psychological disorders (changes in mood, anxiety, signs of depression, suicidal thoughts) or sexual disorders (erection problems, ejaculation problems, decreased libido, etc.), the agency announces that this may come from your treatment. In this case :
- Talk to your doctor as soon as possible;
- If you are being treated for alopecia, in the event of psychological problems, stop your treatment;
- Report an adverse reaction.
If these effects last over time or persist after treatment is stopped, it is important to update your initial declaration to complete it.
If these symptoms appear, you will need to assess whether to continue or stop treatment.