A patient alert card warning of potential psychiatric and sexual side effects of finasteride will be introduced into packs of the medicine this year, following a review into the drug’s safety.

Finasteride is used by men as a 1mg dose under the brand name Propecia to treat hair loss, and as a 5mg dose under the brand name Proscar to treat benign (non-cancerous) enlargement of the prostate.

It has been reported to cause depressed mood, depression, suicidal thoughts, as well as sexual dysfunction that can sometimes persist even after patients stop taking the medicine.

While these side effects are listed in the Patient Information Leaflet (PIL), the Medicines and Healthcare products Regulatory Agency commissioned a review after concerns were raised by patients that these side effects were not well known among patients and healthcare professionals.

This was then considered by the Pharmacovigilance Expert Advisory Group (PEAG) of the Commission on Human Medicines (CHM), which recommended the introduction of a patient card to increase awareness about these risks.

Patients will be encouraged to show this card, and the patient leaflet, to friends and family, as they may not notice changes to their own mood, the MHRA said.

And Dr Alison Cave, MHRA chief safety officer, said that patients taking finasteride 1 mg (Propecia) for hair loss who develop depression or suicidal thoughts should stop treatment and contact their doctor, while those taking finasteride 5 mg (Proscar) for benign enlargement of the prostate, should consult their doctor immediately if they experience depression or suicidal thoughts.

‘Any concerns about sexual dysfunction should be discussed with your healthcare professional,’ she added.

Healthcare professionals have been advised to monitor patients for psychiatric and sexual side effects.

And prescribers have been advised to ask patients if they have a history of depression or suicidal ideation before prescribing finasteride, and to advise them of what to do if they do develop these symptoms while taking the drug.

Any suspected adverse drug reactions associated with finasteride should be reported via the Yellow Card scheme.

Some medicines, such as sodium valproate, must be dispensed in original full packs, after concerns were raised that patients were not receiving the patient safety card that was attached to the original packaging. Pharmacists may round the prescribed amount of valproate-containing medicines either up or down so that the patient receives only complete packs.

Meanwhile, the government intends to allow pharmacists to dispense all medicines according to the amount contained in the original pack, even if this is slightly different to the amount prescribed.