Other safety alerts
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| Singapore: Finasteride and potential risk of suicidal ideation |
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Health Sciences Authority (HSA) announces that 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.
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.
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. 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 Agency, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and the United States’ Food and Drug Administration.
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. 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.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/safety-alert/finasteride-and-potential-risk-of-suicidal-ideation
In Hong Kong, there are 32 registered pharmaceutical products containing finasteride. All products are prescription-only medicines. So far, the Department of Health (DH) has received 4 cases of adverse drug reaction related to finasteride, of which one case was related to depression.
Related news was previously issued by MHRA and Health Canada, and was posted on the Drug Office website on 25 May 2017 and 27 Feb 2019. Letters to inform local healthcare professionals were issued by the DH on 25 May 2017. In Sep 2017, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided that the sales pack label and/or package insert of finasteride-containing products should include safety information on mood alterations (including depression and suicidal ideation). The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, Aug 31, 2022
Issued at HKT 16:00
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