Following a comprehensive safety review of finasteride, the Medicines and Healthcare products Regulatory Agency (MHRA) is asking men taking this medicine to be aware of possible psychiatric (mental health) and sexual side effects.
As a recommendation of the review, a patient alert card will be introduced in the finasteride pack this year to raise awareness of these risks and help ensure patients are informed about what to do if they experience these side effects. Because patients may not notice changes in their mood, they are encouraged to show this card and patient brochure to friends and family. Healthcare professionals have also been reminded to monitor patients for these side effects through a new drug safety update.
Finasteride, a drug used by men to treat hair loss (1 mg dose, brand name Propecia) and benign (noncancerous) enlargement of the prostate (5 mg dose, brand name Proscar) has been reported to , causes a depressed mood. , depression, suicidal thoughts and sexual dysfunction (including decreased sexual desire and inability to achieve and maintain an erection). In some cases, sexual dysfunction has persisted in patients even after they have stopped taking finasteride. However, there is a lack of awareness of these potential side effects.
Before starting finasteride, patients should inform their prescriber of any personal history of depression or suicidal thoughts. Men taking finasteride 1mg (Propecia) for hair loss who develop depression or suicidal thoughts should stop treatment immediately and contact their doctor as soon as possible. Those on up to 5mg finasteride (Proscar) for benign prostate enlargement who develop these symptoms should speak to their doctor urgently for further medical advice.
If patients experience problems with sexual function, such as the inability to achieve and maintain an erection or decreased sexual desire, they should discuss this with their prescriber or physician. All patients are reminded to always read the leaflet that comes with the medicine, which contains important information about taking finasteride and a full list of possible known side effects.
Dr Alison Cave, Chief Safety Officer at the MHRA, said:
It is crucial that patients know vital information about the medicines they take.
The new patient alert cards aim to make men taking finasteride aware of the potential for psychiatric and sexual side effects, so they can make an informed decision about their treatment and know what to do if they experience these side effects.
If you are taking finasteride 1mg (Propecia) for hair loss and develop depression or suicidal thoughts, stop treatment and contact your doctor. If these symptoms develop with Finasteride 5mg (Proscar), for benign prostate enlargement, see your doctor immediately for further advice. Any concerns about sexual dysfunction should be discussed with your healthcare professional.
Remember to always read the leaflet inside the package as it contains important information about how to take finasteride and its possible side effects. Please continue to report any suspected finasteride side effects using the MHRA Yellow Card scheme.
The MHRA completed a safety review of finasteride following concerns raised by patients about a lack of awareness of these side effects among patients and healthcare professionals. The MHRA reviewed the available evidence, including Yellow Card reports, the published scientific literature and the actions of other regulators, and this was considered by the Pharmacovigilance Expert Advisory Group (PEAG) of the Commission Human Medicines (CHM).
The PEAG noted that finasteride’s product information contains information about the risk of depression and suicidal ideation and the potential for persistent sexual side effects after finasteride is discontinued. However, these side effects do not seem to be well known by prescribers and patients, and therefore the introduction of a patient card is recommended to increase awareness of these risks.
Notes to editors
- More information is available in the Public Medicines Safety Assessment and Update Report.
- Finasteride is an inhibitor of 5 alpha-reductase type 2. The dose of 1 mg (Propecia) is indicated in men aged 18 to 41 years for the treatment of male pattern hair loss (androgenetic alopecia). The 5 mg dose (Proscar) is indicated for the treatment and control of benign prostatic hyperplasia in adults.
- While finasteride 5mg (Proscar) is prescribed by the NHS, finasteride 1mg (Propecia) is only available by private prescription and is commonly prescribed online, which may increase the risk that these side effects are underreported.
- An earlier drug safety update for finasteride was published in 2017, but the evidence for possible persistence of sexual dysfunction was insufficient at the time.
- Up to 5 April 2024, the MHRA has received 281 yellow card reports of finasteride (both 1mg and 5mg) relating to finasteride and depressed mood disorders and suicidal behaviour, and self harming Most of these reports are related to depressed mood disorders and 14 of the reports are related to suicidal behaviors. There are 426 yellow card reports related to sexual dysfunction. There is widespread use of this product with average finasteride 5mg prescriptions of approximately 20,000 per month. The MHRA cannot obtain accurate usage data for finasteride 1mg as it is privately prescribed.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK, making sure they work and are acceptably safe. All of our work is based on sound, fact-based judgment to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media inquiries please contact 020 3080 7651 or newscentre@mhra.gov.uk.
#Men #finasteride #urged #vigilant #potential #psychiatric #sexual #side #effects
Image Source : www.gov.uk