The European Medicines Agency (EMA) has begun a review of two popular medications, finasteride and dutasteride, used for hair loss and enlarged prostate issues. This review is prompted by concerns about their potential connection to suicidal thoughts.
Finasteride is known as Propecia when used for male pattern hair loss and Proscar for treating benign prostatic hyperplasia (BPH), a condition that causes an enlarged prostate and difficulties with urine flow. It is marketed by Organon, a spin-off of the pharmaceutical company MSD. Dutasteride, sold as Avodart by GSK, operates similarly and is primarily used for BPH. Avodart is also sometimes used off-label to treat hair loss, and generic versions of both medications are available.
The review was requested by the French regulatory body, the National Agency for the Safety of Medicines and Health Products. They have called for a comprehensive examination of all available data concerning suicidal thoughts linked to finasteride and dutasteride. They aim to assess how these potential risks affect the overall safety and efficacy of these drugs.
French regulators have noted that finasteride and dutasteride can lead to psychiatric side effects. Recently, suicidal ideation was added to the patient information and packaging for Propecia and Proscar in the European Union. However, French authorities contend that the latest safety reports change the risk assessment for finasteride.
On October 4, the Article-31 referral document stated, “Even though a causal association between finasteride and suicidal ideation has not been established, it was considered at least a reasonable possibility.” This is due to known adverse drug reactions (ADRs) like sexual dysfunction, impotence, depression, and decreased libido, which could contribute to suicidal thoughts.
This is not the first time concerns have been raised about the psychiatric effects of these medications. In June 2022, the US Food and Drug Administration (FDA) mandated that warnings about suicidal thoughts and behaviors be added to the drugs’ labels, although they rejected a request to pull Propecia from the market. This followed a 2017 petition from the Post-Finasteride Syndrome Foundation, a patient advocacy group that urged MSD to stop selling the drug or impose stricter warnings.
In April 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) introduced a patient alert card to inform men taking finasteride about the potential psychiatric and sexual side effects.
Androgenetic alopecia, or pattern baldness, is the leading cause of hair loss in men and also affects women. According to GlobalData, there are currently 49 drugs in development for treating this condition.
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