Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) will introduce a patient alert card to boost awareness among men taking finasteride, warning about potential psychiatric and sexual side effects.
The agency is asking men on the medication to stay vigilant for potential psychiatric (mental health) and sexual side effects, and has said that a patient alert card will be introduced into the medication pack this year to raise awareness of these risks.
It suggested that because patients may not notice changes to their mood, they are encouraged to show this card, and the patient leaflet, to friends and family.
Healthcare professionals have also been reminded to monitor patients for such side effects through a new Drug Safety Update.
Finasteride, used by men to treat hair loss (1 mg-dose, brand name Propecia) and benign (non-cancerous) enlargement of the prostate (5 mg-dose, brand name Proscar), has been reported to cause depressed mood, depression, suicidal thoughts and sexual dysfunction (including decreased sex drive and inability to get and maintain an erection).
In some cases, sexual dysfunction has persisted even after patients have stopped taking finasteride.
However, there is a lack of awareness of these potential side effects, and after concerns raised by patients, the MHRA undertook a review of the medication’s safety.
The MHRA reviewed the available evidence, including Yellow Card reports, published scientific literature and actions by other regulators, which was considered by the Pharmacovigilance Expert Advisory Group (PEAG) of the Commission on Human Medicines (CHM).
The PEAG noted that the product information for finasteride contains information regarding the risk of depression and suicidal ideation and the potential of persistent sexual side effects after discontinuation with finasteride. However, these side effects do not appear to be well known by prescribers and patients, hence the recommendation for a patient card.
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