Following an EU-wide review of available data on finasteride and dutasteride medicines, EMA’s safety committee, PRAC, has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1 and 5 mg tablets. The frequency of the side effect is unknown, meaning that it is not possible to estimate it from available data.
Most cases of suicidal ideation were reported in people using 1 mg finasteride tablets, which are used to treat androgenetic alopecia (hair loss due to male hormones). A warning about mood changes, including depression, depressed mood and suicidal ideation, is already included in the product information for finasteride medicines. Patients who experience mood changes should seek medical advice and, if taking finasteride 1 mg, should also stop treatment.
The product information for finasteride 1 mg tablets will now also alert patients about the need to seek medical advice if they experience problems with sexual function (such as decreased sex drive or erectile dysfunction), which are known side effects of the medicine and may contribute to mood changes.
A patient card will be included in the packages of 1 mg finasteride tablets to remind patients of these risks and to advise them about the appropriate course of action.
The recommendations follow a review of the risks of suicidal thoughts and behaviours with finasteride and dutasteride medicines. The PRAC agreed that suicidal ideation should be included as a side effect of finasteride tablets but concluded that the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses.
Finasteride 1 mg tablets and finasteride skin spray are used to treat early androgenetic alopecia (hair loss due to male hormones), while finasteride 5 mg tablets and dutasteride 0.5 mg capsules are used to treat benign prostatic hyperplasia (enlarged prostate that can cause problems with urine flow).
Although it was not possible to establish a link between suicidal ideation and dutasteride based on the reviewed data, dutasteride works in the same way as finasteride and therefore information about the mood changes seen with finasteride will also be added to dutasteride’s product information as a precaution.
The review found no evidence linking suicidal ideation to finasteride skin sprays and no new information is being included in the product information for these sprays.
In reaching its conclusion, the PRAC assessed available information on the effectiveness and safety of finasteride and dutasteride medicines, including data from clinical trials, EudraVigilance (the European database of reported suspected side effects), literature case reports and studies in the scientific literature.
The review identified 325 relevant cases of suicidal ideation in EudraVigilance, 313 reported for finasteride and 13 for dutasteride (with 1 case reported for both). These cases were considered either probably or possibly related to treatment, and most cases concerned patients treated for alopecia. These numbers were considered in the context of an estimated exposure of around 270 million patient years for finasteride and around 82 million patient years for dutasteride (1 patient year is the equivalent of one patient taking the medicine for one year).
The Committee also considered information received during the review from patients or their relatives, healthcare professionals, academics, and patient and consumer organisations, who shared their experiences with finasteride treatment and/or provided additional data on finasteride use.
Medicines containing finasteride 1 mg tablets or sprays to be applied to the skin are authorised in various EU Member States to prevent hair loss and stimulate hair growth in men aged 18 to 41 years with early-stage androgenetic alopecia (hair loss due to male hormones).
Medicines containing finasteride 5 mg tablets and dutasteride (0.5 mg capsules) are authorised to treat symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate is enlarged, which may cause problems with the flow of urine.
In the EU, finasteride- and dutasteride-containing medicines are available under various trade names such as Adadut, Androfin, Andropecia, Avodart, Capila, Combodart, Duodart, Dupro, Duster, Dutaglandin, Dutalosin, Dutascar, Finahair, Finapil, Finapuren, Finaristo, Finpros, Finural, Fynzur, Gefina, Propecia, Proscar, Prosmin, Prosterid, Tadusta and others.
Finasteride and dutasteride work by preventing an enzyme called 5-alpha reductase (5-AR) from changing testosterone (a male hormone) into 5-alpha-dihydrotestosterone (DHT), which is involved in hair loss and enlargement of the prostate. By keeping 5-AR from working, finasteride and dutasteride decrease levels of DHT. This slows down hair loss and stimulates hair growth and decreases the size of the prostate.
The review of medicines containing finasteride and dutasteride was initiated at the request of the French medicines agency, under Article 31 of Directive 2001/83/EC.
The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which has issued a set of recommendations. The PRAC recommendations will now be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position. The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.