EMA Decision Is In: Finasteride Linked to Suicidal Ideation
The advice follows an EU-wide review launched in February of available data on finasteride and dutasteride by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC). The review of the benefit-risk balance was undertaken following notification by France of a referral under Article 31 of Directive 2001/83/EC, based on pharmacovigilance data. It followed a warning by the UK's Medicines and Healthcare products Regulatory Agency in April 2024 that a comprehensive safety review prompted by patient concerns had revealed possible psychiatric and sexual side effects.
PRAC said that it had assessed data from clinical trials, EudraVigilance (the European side effects database), and studies and case reports in the scientific literature, as well as information from patients, relatives, healthcare professionals, academics, and patient and consumer organizations.
EudraVigilance revealed 325 relevant cases of suicidal ideation (313 for finasteride and 13 for dutasteride) considered either probably or possibly related to treatment, most of which related to patients treated for alopecia. However, PRAC pointed out that this was in the context of an estimated exposure of around 270 million patient-years for finasteride and around 82 million patient-years for dutasteride.
Suicidal Ideation Side Effect Confirmed
In conclusion, the committee confirmed suicidal ideation as a side effect of finasteride 1 mg and 5 mg tablets, although it said that the frequency was unknown. A link between suicidal ideation and dutasteride was not established on the basis of the reviewed data, but because dutasteride works in the same way, information about the mood changes seen with finasteride would be added to dutasteride's product information as a precautionary measure, as it already is for finasteride.
However, the committee concluded that the benefits of both finasteride and dutasteride continued to outweigh their risks for all approved uses.
Finasteride is an androgen blocker that acts as a competitive inhibitor of human 5-alpha reductase, an intracellular enzyme that metabolizes testosterone into the more potent androgen dihydrotestosterone. It is used to treat androgenic alopecia in males via 1 mg tablets and cutaneous spray, whereas finasteride 5 mg tablets and dutasteride 0.5 mg capsules are used to treat benign prostatic hyperplasia.
Patients Alerted to Risks
The EMA said that most cases of suicidal ideation were reported in people using 1 mg finasteride to treat male hair loss, and patients should be advised that they should stop treatment and seek medical advice if they experience mood changes. The product information for the 1-mg oral dose will now also alert patients to the need to seek medical advice if they experience problems with sexual function (such as decreased sex drive or erectile dysfunction) that have been reported to contribute to mood alterations and suicidal ideation in some patients. A patient card will be included in the 1-mg finasteride package to remind patients of these risks and to advise them about the appropriate course of action.
The review found no evidence linking suicidal ideation to finasteride skin sprays, and no new information is being included in their product information.
In the EU, finasteride- and dutasteride-containing medicines are available under various trade names, including Adadut, Androfin, Andropecia, Avodart, Capila, Combodart, Duodart, Dupro, Duster, Dutaglandin, Dutalosin, Dutascar, Finahair, Finapil, Finapuren, Finaristo, Finpros, Finural, Fynzur, Gefina, Propecia, Proscar, Prosmin, Prosterid, and Tadusta.
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