Finasteride: Reminder of the risk of psychiatric and sexual side effects

The MHRA has introduced a patient alert card 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 should monitor patients for both psychiatric and sexual side effects.

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
• Report suspected adverse drug reactions associated with finasteride via the Yellow Card scheme

Advice for healthcare professionals to give to patients and caregivers:

• Finasteride is a medicine that helps with the management of male pattern hair loss (androgenic alopecia; 1 milligram (mg) formulation) and benign (non-cancerous) enlargement of the prostate (benign prostatic hyperplasia; 5mg formulation)
• Finasteride has been associated with depressed mood, depression, suicidal thoughts and sexual dysfunction (including decreased sex drive and erectile dysfunction)
• In some cases sexual dysfunction has persisted in patients even after they have stopped taking finasteride
• Before taking finasteride, inform your doctor if you have any personal history of depression or suicidal thoughts
• Stop finasteride 1mg (Propecia) immediately if you develop depression or suicidal thoughts and contact your doctor as soon as possible
• If you are prescribed finasteride 5mg (Proscar) and you develop depression or suicidal thoughts, you should inform your doctor for further medical advice as soon as possible
• If you experience any problems with sexual function such as inability to get and maintain an erection or decrease in sex drive, please discuss this with your prescriber or doctor
• You may not notice some changes in your mood and behaviour so it is very important to tell your friends and family that you are taking this medicine and that it can have effects on psychological well-being. Others may notice changes and help you quickly identify any symptoms that you need to talk to your doctor about
• Always read the leaflet that is provided alongside your medicine, which contains information about taking finasteride and a full list of known possible side effects.

Further details of this MHRA alert are available here.

If you would like to see more MHRA updates of relevance to pharmacy professionals in general practice, please click here.