The European Medicines Agency (EMA) has started a review of popular anti-baldness and enlarged prostate medicines finasteride and dutasteride over concerns about their possible impact on causing suicidal thoughts.
Finasteride is marketed as Propecia for male pattern hair loss (androgenetic alopecia) and Proscar for treating benign prostatic hyperplasia (BPH), by MSD’s spin-off company Organon. BPH is a condition in which the prostate is enlarged causing problems with the flow of urine. Dutasteride, which is marketed by GSK as Avodart, has a similar mechanism of action and is used to treat BPH. Avodart is also sometimes used off label for hair loss, with generic versions of finasteride and dutasteride available in the market.
The safety review was requested by the French regulatory agency, the National Agency for the Safety of Medicines and Health Products, which said that all available data on suicidal ideation and suicide related to finasteride and dutasteride-containing products as well as the impact of these possible risks on the benefit-risk balance of these products should be reviewed.
Finasteride and dutasteride are linked to psychiatric side effects according to French regulators. Suicidal ideation was recently added to the patient information sheets and packaging for both Propecia and Proscar in the EU. However, French authorities argue that the new safety reports alter the risk profile of finasteride.
This was highlighted in the 4 October Article-31 referral document: “Even though a causal association between finasteride and suicidal ideation has not been established, it was considered at least a reasonable possibility, given that known ADRs [adverse drug reactions] such as sexual dysfunction/impotence, depression, decreased libido, may lead to suicidal ideation.”
This is not the first time that questions have been raised about the psychiatric symptoms of these drugs. In June 2022, the US Food and Drug Administration (FDA) ordered a warning about suicidal thoughts and behaviour on the drug’s label but rejected a request to remove Propecia from the market. This followed a 2017 petition from a patient advocacy group called the Post-Finasteride Syndrome Foundation, which ordered MSD to either stop selling the drug or require stronger warnings.
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By GlobalData
In April 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) introduced a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects.
Androgenetic alopecia or pattern balding is the main cause of hair loss in men but affects both men and women. According to GlobalData, there are 49 drugs in development for the condition.
GlobalData is the parent company of Pharmaceutical Technology.
