Europe confirms that suicidal thoughts are a side effect of this popular hair growth product.

Following a European Union (EU) review of available data on finasteride and dutasteride, the European Medicines Agency 's (EMA) safety committee, called the PRAC, has confirmed suicidal ideation (or suicidal thoughts) as a side effect of finasteride 1 mg and 5 mg tablets. The frequency of this side effect is currently unknown.

Most cases of suicidal ideation have been reported in people taking 1 mg finasteride, used to treat androgenetic alopecia . The product information for finasteride medications already includes a warning about mood changes , such as depression , depressed mood, and suicidal ideation. Patients who experience mood changes should consult a doctor and, if taking 1 mg finasteride, should also discontinue treatment.

The product information for finasteride 1 mg will now also alert patients to the need to seek medical advice if they experience problems with sexual function, such as decreased sexual desire or erectile dysfunction, which are known side effects of the drug and can contribute to mood swings. Additionally, a patient-specific card will be included in finasteride 1 mg tablet packs to remind patients of these risks and advise them on the appropriate course of action.

The recommendations arise from a review of the risks of suicidal thoughts and behaviors with finasteride and dutasteride. The PRAC agreed that suicidal ideation should be included as a side effect of finasteride tablets, but concluded that the benefits of these drugs continue to outweigh their risks for all approved uses.

What is finasteride used for?

Finasteride 1 mg tablets and finasteride skin spray are used to treat early androgenetic alopecia , while finasteride 5 mg tablets and dutasteride 0.5 mg capsules are used to treat benign prostatic hyperplasia, i.e., an enlargement of the prostate gland that can cause problems with urine flow .

Although a link between suicidal ideation and dutasteride could not be established based on the data reviewed, dutasteride works in the same way as finasteride, and therefore information about mood changes seen with finasteride will also be added to the dutasteride product information as a precautionary measure.

The review found no evidence linking suicidal ideation with finasteride skin sprays.

The review found no evidence linking suicidal ideation with finasteride skin sprays , and no new information is included in the product information for these sprays.

To reach its conclusion, the PRAC assessed the available information on the efficacy and safety of the medicines finasteride and dutasteride, including data from clinical trials, EudraVigilance—the European database of reported suspected side effects—case reports in the literature, 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 one case reported for both). These cases were considered probably or possibly treatment-related, and most involved patients treated for hair loss. These figures were considered in the context of an estimated exposure of approximately 270 million patient-years for finasteride and approximately 82 million patient-years for dutasteride. One patient-year is equivalent to 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 organizations, who shared their experiences with finasteride treatment and/or provided additional data on the use of finasteride.