Hair transplantation: effective and safe, without medication

Dr. López Bran, why do these anti-hair loss drugs raise concerns among the population, especially men?

“Among the different options dermatologists have to address androgenetic alopecia, oral finasteride 1 mg, topical finasteride, and oral dutasteride 0.5 mg are surrounded by controversy due to the possible appearance of adverse side effects, which can be very serious for some patients,” he explains.

“For this reason, specialists in the field feel the need to share the information currently available, as indicated by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) and the Spanish Agency of Medicines and Medical Devices (AEMPS),” he adds.

Last May, the AEMPS reported cases of suicidal ideation in patients treated with oral finasteride 1 mg and topical finasteride, mainly in those receiving treatment for male androgenetic alopecia; although the evaluation also included finasteride 5 mg and dutasteride 0.5 mg in patients with benign prostatic hyperplasia.

The European database of suspected adverse drug reactions (EudraVigilance) reviewed 325 reported cases of patients with depressed mood, depression, or suicidal ideation: 313 were associated with finasteride.

The remaining 13 cases, linked to dutasteride, do not allow a causal relationship with suicidal thoughts to be confirmed. However, due to its mechanism of action—similar to finasteride, as both inhibit 5-alpha-reductase—it is considered a possible class effect.

At the same time, and despite being listed in the package leaflet for finasteride 1 mg, this medicine may cause sexual dysfunction, which could contribute to the development of mood disorders in patients.

In fact, the PRAC concluded that the level of evidence for these risks varies depending on the indications, active substances, and formulations evaluated.

“Hopefully, the different studies already underway will help clarify the reality of the relationship between the adverse effects reported and the use of these drugs. As professionals, we have the obligation to provide truthful and rigorous information, with common sense, to our patients,” Dr. López Bran emphasizes.