Medicines containing finasteride or dutasteride are prescribed for baldness. Faced with multiple side effects, the European Medicines Agency is conducting new research on its benefits and risks.
- Finasteride is a medication indicated for the treatment of baldness.
- Several side effects have been reported, including mood disorders and sexual dysfunction.
- The European Medicines Agency is mobilizing its pharmacovigilance committee to reassess its benefit/risk balance.
Treatments for baldness raise concerns. In a press releasethe National Medicines Safety Agency announces that a re-evaluation of a group of drugs is underway. The European Medicines Agency is interested in finasteride and dutasteride, prescribed “in early stages of androgenic alopecia in men aged 18 to 41″. Androgenic alopecia refers to hair loss linked to hormonal changes.
Reassessment at our request of the benefit/risk of #drugs with #finasteride or dutasteride by @EMA_News
⚠️They present risks of sexual and psychiatric disorders, described in the instructions, and which we keep under surveillance
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— ANSM (@ansm) October 18, 2024
Baldness: which medication is affected?
The European Medicines Agency and its Pharmacovigilance Committee are working on three treatments: finasteride 1 mg, finasteride 5 mg and dutasteride 0.5 mg. All of them can be prescribed against baldness. “These medications present risks of sexual dysfunction and psychiatric disorders which are described in the instructions and for which we maintain monitoring, explains the ANSM. 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.
Treatment against baldness: persistent side effects
Since 2019, the agency has put in place systems to warn about side effects, in order to limit them as much as possible: information sheet for patients, prevention messages on the boxes, alerts to doctors. “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, notes the agency. Additionally, suicidal ideation has recently been recognized as a potential adverse effect for two finasteride-containing medications (Propecia 1 mg and Chibro-Proscar 5 mg).” Faced with these reports, the European Medicines Agency is mobilizing its pharmacovigilance committee to update its assessment of the benefits and risks of these medicines.
What to do if you are taking treatment for baldness?
While awaiting the results, the ANSM provides various advice to patients who take these medications to treat alopecia. “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…), this may come from your treatment”warns the ANSM. Faced with these symptoms, she recommends speaking with a health professional as quickly as possible. If the medication is prescribed for hair loss, and psychological symptoms appear, you must stop the treatment and make a report of an adverse effect on the agency’s website.
