Other safety alerts
|
| |
| European Union: EMA has started a review of medicinal products containing finasteride and dutasteride |
| |
European Medicines Agency (EMA) announces that the Pharmacovigilance Risk Assessment Committee (PRAC), has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviours.
Tablets containing 1 mg of finasteride and finasteride solution for application to the skin are used to treat the early stages of androgenic alopecia (hair loss due to male hormones) in men aged 18 to 41 years. Tablets containing 5 mg finasteride and capsules containing 0.5 mg dutasteride are used to treat men with benign prostatic hyperplasia (BPH), a condition in which the prostate is enlarged and can cause problems with the flow of urine.
During the review, PRAC will assess all available data linking finasteride and dutasteride to suicidal ideation and behaviours. It will also evaluate the impact of suicidal ideation and behaviours on the benefit-risk balance of these medicines, taking into consideration the conditions they are used to treat.
Medicines containing finasteride and dutasteride taken by mouth have a known risk of psychiatric side effects, including depression. Suicidal ideation has also recently been added as a possible side effect of unknown frequency in the product information for Propecia and Proscar, the first two finasteride-containing medicines authorised in several countries of the European Union (EU). To minimise the risks, measures are already in place for finasteride medicines, including warnings in the product information for healthcare professionals to monitor patients for psychiatric symptoms and stop treatment if symptoms occur, and recommendations for patients to seek medical advice if they experience psychiatric symptoms.
EMA will now review all available data on suicidal ideation and behaviours with finasteride and dutasteride and issue a recommendation on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/medicines/../finasteride-dutasteride-containing-medicinal-products
In Hong Kong, there are 31 and 9 registered pharmaceutical products containing finasteride and dutasteride respectively. All products are prescription-only medicines. The Department of Health (DH) has received 5 cases of adverse drug reaction related to finasteride and 4 cases of adverse drug reaction related to dutasteride, but these cases were not related to suicidal ideation and behaviours.
Related news on the risk of psychiatric side effects associated with the use of finasteride was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 25 May 2017, with the latest update posted on 30 Apr 2024. Letters to inform local healthcare professionals were issued by the DH on 25 May 2017 and 20 Jan 2023. In Sep 2017 and Apr 2024, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and in Sep 2017 the Committee decided that the sales pack label and/or package insert of finasteride-containing products should include the relevant safety information. The DH will remain vigilant on the review started by EMA and any safety update of the drugs issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, Oct 5, 2024
Issued at HKT 12:00
|
| |
|
