Once a Hope for Hair Loss Patients... "Treatment Causes Suicidal Thoughts"

Possibility of Suicide Induction, European Medicines Agency (EMA) Begins Safety Review

A full-scale investigation has begun into the possibility of psychiatric side effects caused by drug ingredients widely used in male hair loss treatment.

The target drugs contain 'Finasteride' and 'Dutasteride.' In South Korea, where the population concerned about hair loss reaches 10 million, generic versions of these two ingredients hold a high market share, so significant repercussions are expected depending on the review results.

(This photo is not directly related to the article.) [Photo source=Pixabay]

Maeil Business Newspaper reported on the 6th that the Pharmacovigilance Risk Assessment Committee (PRAC) under the European Medicines Agency (EMA) held a meeting from the 30th of last month to the 3rd of this month (local time) and has begun deliberations on hair loss treatments containing 'Finasteride' and 'Dutasteride' amid concerns about suicidal impulses and actions.

Propecia (Finasteride) by MSD in the United States and Avodart (Dutasteride) by GSK in the United Kingdom each contain the respective ingredients. Both ingredients are also widely used in generic drugs produced by domestic pharmaceutical companies. These two ingredients are prescription medicines that require guidance from doctors and pharmacists during prescription and intake, as they have well-known side effects such as decreased libido, erectile dysfunction, and depression.

The European EMA may cancel the approval or suspend the marketing of these drugs through this review. The two ingredients were initially approved as treatments for benign prostatic hyperplasia but later obtained indications for androgenetic alopecia in adult men due to demonstrated efficacy.

(This photo is not directly related to the article.) [Photo source=Pixabay]

The EMA plans to evaluate all available data related to Finasteride and Dutasteride concerning suicidal impulses and behaviors. Through this, they will analyze the impact on the balance between the therapeutic benefits of the drugs and the risk of suicidal behavior.

In clinical and post-marketing surveillance (PMS), oral forms of these two ingredients have been reported to carry risks of psychiatric side effects, including depression. The French National Agency for the Safety of Medicines and Health Products (ANSM) stated, "Although a causal relationship between Finasteride and suicidal impulses has not been clearly established, considering that known adverse drug reactions such as sexual dysfunction, erectile dysfunction, depression, and decreased libido can induce suicidal impulses, it is at least regarded as a reasonable possibility," and called for a safety review.

Meanwhile, according to the Health Insurance Review & Assessment Service, the number of hair loss patients is about 240,000, but the medical community estimates that the actual number of people suffering from hair loss is much higher. Many avoid visiting hospitals for hair loss due to social stigma. In the HIRA statistics, about 23% of all patients are in their 40s, the largest group, followed by those in their 30s at about 22%. The annual patient growth rate is an average of 2.5%, showing a continuing upward trend.