GPs should ask patients if they have a history of depression before prescribing prostate and hair loss drug finasteride, the medicines regulator has said.
A patient alert has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) about side effects associated with the drug.
The MHRA warned men taking the drug to be vigilant for potential psychiatric and sexual side effects.
It comes after a safety review of finasteride which found the drug has been linked to depression, suicidal thoughts and sexual dysfunction.
GPs should ask patients if they have a history of depression or suicidal ideation before prescribing the treatment, the MHRA said.
Men should also be advised to stop taking 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.
For those taking 5mg (Proscar) for benign prostatic hyperplasia, the advice is to consult their doctor as soon as possible if they develop depression or suicidal thoughts.
The review also found that patients have reported that sexual side effects which include decreased libido and erectile dysfunction have persisted even after treatment was stopped and the MHRA reminded healthcare professionals to monitor patients for psychiatric and sexual side effects.
In response to the update, a patient alert card will be introduced in all packs of finasteride to increase awareness for patients and prescribers, the MHRA added.
A previous drug safety update had been issued in 2017 but at the time the potential for persistence of some of the side effects was not well known, the review which looked at Yellow Card reports as well as published literature said.
Since 1992 there had been 426 Yellow Card reports of finasteride and sexual dysfunction with the issue recorded as not recovered or not resolved in almost half of cases.
The MHRA had also received 281 reports of finasteride and depressed mood disorders and suicidal and self-injurious behaviours since 1993.
The review concluded that there had been information on these side effects included in the patient information leaflet it was not well known by prescribers or patients.
Dr Alison Cave, MHRA chief safety officer, said: ‘It’s crucial that patients are aware of vital information about the medicines they’re taking.
‘The new patient alert cards aim to raise awareness among men taking finasteride about 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.
She also urged healthcare professionals to continue to report any suspected side effects from finasteride via the MHRA Yellow Card scheme”.
