Other safety alerts
|
| |
| The United Kingdom: Finasteride: rare reports of depression and suicidal thoughts |
| |
The Medicines and Healthcare products Regulatory Agency (MHRA) advised that the MHRA has received reports of depression and, in rare cases, suicidal thoughts in men taking finasteride 1 mg (Propecia) for male pattern hair loss. The public should be aware that depression is also associated with finasteride 5 mg (Proscar).
Finasteride is a 5α-reductase-type-2 inhibitor. In the 1 mg dose (Propecia), it is indicated for the treatment of male pattern hair loss (androgenetic alopecia). In the 5 mg dose (Proscar), it is indicated for the treatment and control of benign prostatic hyperplasia.
Some men have reported episodes of depressive illness in association with the use of Propecia for male pattern hair loss. Some men also reported having suicidal thoughts.
Depression and suicidal thoughts have been reported in men with and without a previous history of depression. Depressed mood has been previously recognised with Propecia. A recent review of the evidence has suggested more significant depression can occur and so the advice is being updated to reflect this.
The product information for Proscar in UK already lists depression as a possible adverse reaction and is being updated in light of a recent review.
The MHRA advised healthcare professionals of the followings:
• since finasteride has been marketed there have been a number of spontaneous adverse drug reaction reports suggesting a possible link to depression, and in rare cases, suicidal thoughts
• advise patients to stop finasteride 1 mg (Propecia) immediately if they develop depression and inform a healthcare professional
• be aware that the product information for finasteride 5 mg (Proscar) already lists depression as a possible adverse reaction
Healthcare professionals are reminded that adverse reactions related to sexual function have been reported in association with finasteride. These include decreased libido, erectile dysfunction, and ejaculation disorders (such as decreased volume of ejaculate).
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/finasteride-rare-reports-of-depression-and-suicidal-thoughts
In Hong Kong, there are 35 registered pharmaceutical products containing finasteride, including 1mg tablets (13 products) and 5mg tablets (22 products), and they are prescription only medicines.
Related news regarding changes to the professional labels for finasteride 1 mg and 5 mg to expand the list of sexual adverse events reported to FDA as some of these events have been reported to continue after the drug is no longer being used was issued by US FDA and was posted on the Drug Office website on 13 April 2012. The Department of Health (DH) had issued letters to inform local healthcare professionals on the risk on 13 April 2012. The matter has been discussed by the Registration Committee of the Pharmacy and Poisons Board on 17 February 2015 and concluded that sales pack labels and/or package inserts should be updated with the new safety warnings by US FDA. So far, the DH has received one case of adverse drug reaction in connection with finasteride products which is not related to depression, suicidal thoughts or sexual dysfunction.
In view of the significant depression with suicidal thought with finasteride reported in the above MHRA announcement, DH will issue letters to update local healthcare professionals, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, May 25, 2017
Issued at HKT 15:00
|
| |
|
