Finasteride and potential risk of suicidal ideation

Suicidal ideation is a known adverse event (AE) observed with the use of finasteride post-market and is listed in the local package inserts of finasteride-containing products. A recent pharmacovigilance study by Nguyen et al. suggested that younger patients with alopecia may be more vulnerable to the risk of suicidality, although this association might be biased by stimulated reporting.1

Finasteride has been registered in Singapore since 1993. It is currently indicated for the treatment of benign prostatic hyperplasia and androgenic alopecia.

Pharmacovigilance study of suicidality with finasteride

In the study, disproportionality analysis was used to assess whether suicidality or psychological adverse events (AEs) were more frequently reported for finasteride than would be expected by chance alone by comparing them against similar reports for all other drugs in VigiBase, the World Health Organisation’s global safety database. The study identified 356 reports of suicidality (suicidal ideation, attempted suicide, or completed suicide) and 2,926 reports of psychological AEs (depression or anxiety) in users of finasteride, reported from 1993 to 2019. Among the reports with data available, the majority (99%) occurred in males, and 71% occurred in individuals aged between 18 and 44 years. Significant disproportionality signals for suicidality (reporting odds ratio [ROR], 1.63; 95% CI, 1.47-1.81) and psychological AEs (ROR, 4.33; 95% CI, 4.17-4.49) were identified in finasteride users. In addition, when stratified by age and indication, younger patients less than 45 years old (ROR 3.47, 95% CI 2.90-4.15) and patients with alopecia (ROR 2.06, 95% CI 1.81-2.34) had significant disproportionality signals for suicidality that were not present in older patients or patients with benign prostatic hyperplasia. Conversely, this disproportionality in reporting of suicidality or psychological AEs was not observed for drugs with similar indications but different mechanisms of action (tamsulosin and minoxidil) or similar mechanisms of action and AE profiles (dutasteride).

The study also found that suicidality and psychological AE reports were highest in 2015 to 2019 (81.5% and 78.8%, respectively). Sensitivity analyses showed a disproportionate signal of reporting after the year 2012 (ROR, 2.13; 95% CI, 1.91-2.39), following widespread publicisation of a potential link between finasteride and psychological morbidity. This suggests a reporting bias of stimulated reporting during these years that merits further investigation.

International situation

In 2019, Health Canada completed its latest safety review on the risk of suicidal thoughts and/or behaviour in response to reported domestic and international cases of suicidal ideation and self-injury.2 While the international reports, literature, and regulatory information reviewed could neither confirm nor deny a causal relationship between finasteride and suicide/self-injury, Health Canada concluded that there may be a link between finasteride and the risk of suicidal ideation and updated the Canadian product information to include a warning on this potential safety issue. Similar product information updates had also been implemented by the Australian Therapeutic Goods Administration, the European Medicines Agency3, the United Kingdom’s Medicines and Healthcare products Regulatory Agency4 and the United States’ Food and Drug Administration5.

Local situation

To date, HSA has received one report in 2014 of a 19-year-old male who developed severe mental depression with suicidal tendency after one month’s use of finasteride 1mg. The patient recovered fully several weeks after stopping the medication.

The local package inserts of finasteride-containing products currently list depression and suicidal ideation as psychiatric AEs observed post-market.

HSA’s advisory

Mood alterations including depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride. Healthcare professionals are advised to consider the potential risk of psychological AEs when assessing the benefit-risk of finasteride for their patients.

References

  1. JAMA Dermatol. 2021;157(1):35-42
  2. https://hpr-rps.hres.ca/reg-content/summary-safety-review-detail.php?lang=en&linkID=SSR00218#footnotes
  3. https://www.ema.europa.eu/documents/psusa/finasteride-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00001392/201608_en.pdf
  4. https://www.gov.uk/drug-safety-update/finasteride-rare-reports-of-depression-and-suicidal-thoughts
  5. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020788s030lbl.pdf
Healthcare professional, Industry member, Therapeutic Products
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