The Medicines and Healthcare products Regulatory Agency (MHRA) announced this week (April 29) that it will issue a new patient alert card for popular hair loss drug finasteride amid psychiatric and sexual side effect concerns.
According to the MHRA, finasteride was reported by some patients as causing “depressed mood, depression, suicidal thoughts and sexual dysfunction”.
It noted that some patients reported persistent sexual dysfunction, even after stopping their finasteride use.
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The MHRA said that it will introduce the patient alert card to all packs of finasteride “this year” to alert patients to the drug's risks and to provide guidance should they experience worrying side effects.
The medicines regulator added that patients “may not notice changes to their mood” and “encouraged” them to alert loved ones to the drug’s risks by showing “friends and family” the new card and the patient leaflet.
Healthcare professionals should also monitor patients using finasteride for these side effects, it said.
“Lack of awareness”
The regulator said that there was a “lack of awareness of these potential side effects”.
There is “widespread use” of finasteride 5mg (known as Proscar), which is prescribed by the NHS to approximately 20,000 men per month for “benign enlargement of the prostate”, it added.
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However, finasteride 1mg (known as Propecia) is used to treat hair loss in men and is only available as a private prescription, often using online means, it said.
This means the MHRA does not have accurate data on its use and patients may be at an increased risk of receiving poor information on its side effects, it added.
“Comprehensive” safety review
It comes after a “comprehensive” MHRA safety evidence review of the drug, which included its Yellow Card reports alongside “published scientific literature” and other regulatory action, the MHRA said.
The MHRA’s review was examined by the Pharmacovigilance Expert Advisory Group (PEAG) of the Commission on Human Medicines (CHM), which recommended the introduction of the patient alert card, it added.
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The PEAG noted that the patient information leaflet did warn about the risk of side effects including suicidal ideation but that these seemed not to be “well known by prescribers and patients”, according to the MHRA.
MHRA chief safety officer Dr Alison Cave said that the newly introduced patient alert cards “aim to raise awareness” about finasteride’s possible “psychiatric and sexual side effects”.
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Dr Cave warned patients using finasteride 1mg to “stop treatment” and contact their doctor if they “develop depression or suicidal thoughts”.
She advised patients using finasteride 5mg to “immediately” contact their doctors if they experience these side effects.
And she added that patients should report “any suspected side effects from finasteride” to the MHRA using its Yellow Card scheme.
Drug safety latest
In March, Dr Cave told C+D that the MHRA is considering “whether any further regulatory action is required” for asthma drug montelukast after a rise in Yellow Card reports.
In February, the MHRA announced that codeine linctus would be reclassified from a pharmacy (P) medicine to prescription-only medicine (POM) status, due to "the risk of abuse, dependency and overdose".
And in December, the regulator "reminded" healthcare professionals that patients taking an “important” antipsychotic treatment for schizophrenia and bipolar disorder should be warned of the risk of developing gambling addictions.
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