The European Medicines Agency (EMA) has launched a review of popular hair loss and prostate enlargement drugs finasteride and dutasteride over concerns they may have an effect on inducing suicidal thoughts.
Finasteride is marketed by MSD spin-off company Organon as Propecia for androgenetic alopecia (male pattern baldness) and Proscar for the treatment of benign prostatic hyperplasia (BPH). Benign prostatic hyperplasia is a disease in which the prostate gland enlarges, causing problems with urine flow. Dutasteride, sold as Avodart by GSK, has a similar mechanism of action and is used to treat benign prostatic hyperplasia. Avodart is sometimes used off-label for hair loss, and generic versions of finasteride and dutasteride are available on the market.
The safety review was requested by the French regulator, the National Agency for Medicines and Health Products Safety, which will review all available data on suicidal ideation and suicide related to finasteride- and dutasteride-containing products, as well as the possibility of I mentioned the effects of gender. You should consider the risks involved in balancing the benefits and risks of these products.
Finasteride and dutasteride have been linked to psychiatric side effects, according to French regulators. Recently, suicidal ideation was added to the patient information sheets and packaging for both Propecia and Proscar in the EU. However, French authorities claim that new safety reports have changed finasteride’s risk profile.
This was highlighted in the Article 31 Inquiry Paper of 4 October: “While a causal relationship between finasteride and suicidal ideation has not been established, Considering that it was at least a reasonable possibility that “dysfunction/impotence, depression, and low libido could lead to suicidal ideation.” ”
This is not the first time questions have been raised about the psychiatric effects of these drugs. In June 2022, the U.S. Food and Drug Administration (FDA) ordered drug labels to include warnings about suicidal thoughts and behavior, but rejected a request to remove Propecia from the market. This follows 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.
In April 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) introduced patient warning cards to raise awareness of potential psychiatric and sexual side effects in men taking finasteride. I did.
Androgenic alopecia, or pattern hair loss, is the main cause of hair loss in men, but it affects both men and women. According to GlobalData, 49 drugs are under development for this condition.
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“EMA begins review of hair loss drugs for potential link to suicidal thoughts” was originally created and published by Pharmaceutical Technology, a brand owned by GlobalData.
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