EMA Launches Review of Finasteride for Suicidal Ideation

The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (EMA) has started a review of medicines containing finasteride and dutasteride following concerns about associated suicidal ideation and behaviors. 

Medicines containing finasteride (5 mg tablets) and dutasteride (src.5 mg capsules) are approved to treat symptoms of benign prostatic hyperplasia. Products containing finasteride are also used orally (1 mg tablets) or as a spray to prevent hair loss and stimulate hair growth in men aged 18-41 years with early-stage androgenic alopecia. Both work by inhibiting the enzyme 5-alpha reductase responsible for the conversion of testosterone to 5-alpha-dihydrotestosterone, thus slowing hair loss, stimulating hair growth, and reducing the size of the prostate.

Suicidal Ideation Frequency Unknown

Both drugs, when taken orally, are known to impart a risk for psychiatric side effects, including depression, but the frequency is uncertain. 

Suicidal ideation has recently been added as a possible side effect of unknown frequency in the product information for finasteride brands Propecia and Proscar. 

To minimize the risks, measures are already in place for finasteride, including warnings to healthcare professionals to monitor patients for psychiatric symptoms and stop treatment if symptoms occur. There are also recommendations for patients to seek medical advice if they experience psychiatric symptoms.

The EMA review, initiated at the request of the French medicines agency, will use all available data to evaluate the impact of suicidal ideation and behaviors on the benefit-risk balance of the drugs, taking into consideration the conditions they are used to treat. 

In the European Union, finasteride- and dutasteride-containing medicines are available as tablets or spray solutions under various trade names including Propecia, Proscar, Fynzur, Avodart, Combodart, Dutaglandin, Androfin, Dupro, Duster, Andropecia, Adadut, Prosterid, Finpros, Tadusta, Gefina, Dutascar, Finural, Finaristo, Finapil, Prosmin, Finapuren, Capila, Finahair, Duodart, and Dutalosin.

Questions to Be Answered

During the review, the marketing authorization holders will be asked to provide information and answer various questions including:

• What information on psychiatric disorders, suicidal ideation, and/or suicide is included in the summary of product characteristics, package leaflet, and labelling (ie, inner and/or outer packaging).
• Any important differences in the product information in different countries.
• Any additional risk minimization measure(s) related to psychiatric disorders in place in each country, as well as the timing of their implementation.
• A detailed analysis of all relevant nonclinical data, clinical trials data, pharmaco-epidemiological studies, and published literature on suicidal ideation and/or suicide following finasteride or dutasteride use as applicable.
• A discussion on the causal relationship between suicidal ideation and/or suicide and treatment with finasteride or dutasteride, as well as a discussion on the characterization of possible risk factors including age, dose, route of administration, treatment duration, other known adverse drug reactions (such as persistent sexual disorders), and personal history of psychiatric disorders.
• The effectiveness of the current risk minimization measures in place regarding psychiatric disorders.
• A critical appraisal of the impact of suicidal ideation and/or suicide events on the benefit-risk balance of the medicinal product(s) in each approved indication.
• Proposals and justifications for further measures to minimize suicidal ideation and/or suicide and the feasibility of these measures.

On consideration of all these factors, the EMA will then issue a recommendation on whether the marketing authorizations for finasteride and dutasteride should be maintained, varied, suspended, or withdrawn across the European Union.

Dr Sheena Meredith is an established medical writer, edito