引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
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| The United Kingdom: Finasteride reminder of the risk psychiatric side effects and of sexual side effects (which may persist after discontinuation of treatment) (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that a patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after treatment has stopped. Healthcare professionals are reminded to monitor patients for both psychiatric and sexual side effects.
MHRA completed a safety review into finasteride following concerns from patients regarding a lack of awareness of these side effects amongst patients and healthcare professionals. A previous Drug Safety Update for finasteride was issued in 2017, however at the time the potential for persistence of some of the side effects were not widely known. MHRA recently reviewed the available evidence, including Yellow Card reports, published scientific literature and actions by other regulators, and this was considered by the Pharmacovigilance Expert Advisory Group (PEAG) of the Commission on Human Medicines. The PEAG noted that the product information for finasteride contains information regarding the potential for persistent sexual side effects after discontinuation with finasteride and depression and suicidal ideation. However, these side effects are not well known by prescribers and patients and therefore a Drug Safety Update article was recommended.
The PEAG also recommended inclusion of a patient card inside the pack. The card aims to increase awareness of the side effects including depression, suicidal thoughts and sexual dysfunction, and to advise patients on what to do if they experience these adverse effects. The patient card will be introduced this year.
Since the first report was received in Nov 1992, MHRA has received 426 Yellow Card reports up until 5 Apr 2024 of finasteride (both 1mg and 5mg formulations) and sexual dysfunction, including reports of erectile dysfunction (inability to get and maintain an erection) and decreased sex drive. In almost half of these reports, the outcome was recorded as ‘not recovered’ or ‘not resolved’.
Since the first report was received in Feb 1993, MHRA has received 281 reports of finasteride and depressed mood disorders and suicidal and self-injurious behaviours, up until 5 Apr 2024.
Advice for healthcare professionals:
• finasteride has been associated with depression, suicidal thoughts and sexual dysfunction
• patients have reported that sexual dysfunction (including decreased libido and erectile dysfunction) has persisted even after treatment was stopped
• before prescribing finasteride, ask patients if they have a history of depression or suicidal ideation
• advise patients to stop finasteride 1mg (Propecia) for male pattern hair loss immediately if they develop depression or suicidal thoughts and to contact their doctor as soon as possible
• advise patients prescribed finasteride 5mg (Proscar) for benign prostatic hyperplasia to consult their doctor for further medical advice as soon as possible if they develop depression or suicidal thoughts
• monitor patients for psychiatric and sexual side effects
• a patient card will be introduced in all finasteride packs, which will highlight the risk of sexual side effects and psychiatric side effects reported with finasteride to increase awareness among patients and prescribers
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/finasteride-reminder-of-the-risk-psychiatric-side-effects-and-of-sexual-side-effects-which-may-persist-after-discontinuation-of-treatment
In Hong Kong, there are 31 registered pharmaceutical products containing finasteride. All products are prescription-only medicines. So far, with regard to finasteride, the Department of Health (DH) has received 5 cases of adverse drug reaction, of which 2 cases were reported as decreased libido, erectile dysfunction and depression.
Related news on the risk of psychiatric side effects and of sexual 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 20 Jan 2023. Letters to inform local healthcare professionals were issued by the DH on 25 May 2017 and 20 Jan 2023. 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 the relevant safety information. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Tuesday, Apr 30, 2024
Issued at HKT 18:30
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