POSTED: 14 Oct 2024

Finasteride Could be Facing a Ban for Hair Loss, Here are the Serious Risks That Triggered a Review

Oral Finasteride (licensed under brand name Propecia), is used to treat conditions like male pattern baldness and benign prostatic hyperplasia. However, serious concerns have emerged about the potentially serious and long term side effects of Finasteride in men and women. This has a review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as well as other medical regulators. These concerns centre around a set of serious side effects including mental health issues and sexual health risks. It also includes a set of persistent symptoms collectively known as Post-Finasteride Syndrome (PFS). Beyond the sensationalist headline, it can be hard to understand what has triggered this review and the current guidance. We’ll explore these risks, why the MHRA is conducting a review, whether there’s a Finasteride ban and the updated guidance. We’ll also review whether this review affects topical Finasteride and what it potentially means for similar medications such Dutasteride.

What are the Mental Health Risks & Sexual Side Effects of Finasteride?

Finasteride is facing a review due to a number of studies highlighting alarming mental health and sexual side effects. Men taking Finasteride have reported increased symptoms of anxiety, depression and even suicidal thoughts. We do not fully understand the mechanism behind these mental health effects. However, the suspicion is that it relates to Finasteride’s influence on neurosteroids. These are chemicals in the brain that help regulate mood and Finasteride can reduce their levels. For some individuals, this reduction has led to severe psychological side effects, ranging from mood disturbances to profound depression. In fact, there have been reports of individuals experiencing suicidal ideation after starting Finasteride. This alarming side effect is what has garnered much-needed attention from health authorities.

Sexual health risks are among the most significant concerns for those taking Finasteride. Men using the drug have reported a range of sexual side effects. These include decreased libido, erectile dysfunction, and reduced semen volume. These issues can have a profound impact on quality of life, affecting both physical health and emotional well-being. The sexual side effects are not always temporary. For some individuals, these issues persist even after discontinuation of the drug. This is a core component of Post-Finasteride Syndrome (PFS), where men continue to experience sexual dysfunction long after stopping finasteride.

Women, although less frequently prescribed Finasteride, are also at risk of side effects including changes in mood and sexual function. In general Finasteride should not be given to pregnant women or those who may become pregnant. In fact, they should be specifically warned against handling crushed or broken Finasteride tablets. This is because the drug can cause birth defects.

Post Finasteride Syndrome & Long Term Side Effects

One of the most debated consequences of Finasteride use is Post Finasteride Syndrome (PFS). This is a condition whereby side effects continue to affect some men long term after they stop taking Finasteride. PFS is characterised by a range of persistent symptoms, including sexual dysfunction, cognitive impairment and emotional instability. These symptoms can persist for months or even years after discontinuation. Although there is a lot of debate around the nature for this condition, the potential permanence of side effects has raised serious concerns. As such there is discussion whether Finasteride should carry more severe warnings and whether its use requires greater restriction.

What Triggered the MHRA Review into Finasteride?

In early 2024 the MHRA decided to conduct a review of Finasteride following an increase in reported adverse events. There was particular concern regarding the effects on mental health. Reports submitted to regulatory bodies have highlighted numerous instances of severe psychological distress and prolonged physical symptoms following Finasteride use. The MHRA sought to assess whether the current safety information patients get is adequate and if the labelling on Finasteride products needs an update. This review also focuses on whether healthcare professionals have sufficient information about the potential risks. Mainly whether it allows them to provide better guidance to patients before prescribing the drug. This is especially relevant as many individuals turn to Finasteride for cosmetic reasons such as to prevent hair loss. The MHRA’s review underscores the importance of weighing these potential risks against the benefits of treating a non-life-threatening condition.

What was the Outcome of the MHRA Review – Will There Be a Ban on Finasteride?

In April 2024, in response to growing concerns, the MHRA issued updated guidance on Finasteride for both prescribers and patients. There is now emphasis on healthcare professionals discussing the full spectrum of potential side effects with patients before prescribing Finasteride. This includes highlighting the risk of persistent sexual dysfunction and mental health problems even after discontinuation (Post Finasteride Syndrome).

The advice for patients currently taking Finasteride is to be vigilant about any changes in mood or sexual health. If they notice symptoms such as increase in anxiety, depression, or difficulty with sexual function, they should consult their healthcare provider immediately. Discontinuing Finasteride may help alleviate some of these side effects, but for others, the symptoms may persist, underscoring the importance of early intervention.

The MHRA review into side effects is still ongoing and as such there has been no decision yet on whether there will be a ban on Finasteride use in men or women. The review aims to determine whether additional safety measures are necessary, but there is no explicit mention of a ban at this stage. In comparison, other regulators like the Food & Drug Administration (FDA) in the US and European Medicines Agency (EMA) in the European Union were also also monitoring the safety of Finasteride. Following the MHRA’s review, the EMA recently announced a review of both Finasteride and Dutasteride and possible links to mental health risks. The FDA already issued an additional a warning in 2017 to prescribers regarding risks of suicidal ideation related to both these drugs but has not banned their use.

What About Topical Finasteride?

As the reviews and studies largely relate to oral Finasteride, there’s a debate whether topical Finasteride might be safer. Topical Finasteride is an unlicensed hair loss treatment applied directly to the scalp. This theoretically reduces the systemic absorption of the drug and thereby minimises risk of side effects like sexual dysfunction and mental health issues. Some studies have shown that topical Finasteride can reduce hair loss with fewer systemic side effects compared to oral. However, the evidence is still emerging and it is not yet clear whether topical Finasteride is entirely free of the risks found in the oral version. As such it is best to proceed with caution and assume that the risks apply to all forms of Finasteride. Your provider should look for any factors that could potentially increase your risk of side effects. They should also provide careful monitoring if you start either oral or topical treatment.

Where Does This Leave Dutasteride?

Dutasteride, another 5-alpha-reductase inhibitor, is sometimes used off-license for hair loss. It is more potent than Finasteride but there are fewer studies on its safety and efficacy because it is less commonly used. It is probably safest to assume at least a similar risk of side effects unless evidence in future proves otherwise. Given the MHRA’s review of Finasteride, it is possible that they will also scrutinise Dutasteride. This is especially if reports of adverse long term side effects continue to emerge. This is why anyone considering Dutasteride as an alternative to Finasteride should be aware of the similar risk profile and discuss these risks thoroughly with their healthcare provider.

Finasteride is a powerful drug but the possible risks and long term side effects on men and women need careful consideration. Whilst the drug can be effective in treating hair loss and BPH, there are some serious side effects including mental health problems, sexual dysfunction and the potentially permanent impact of Post Finasteride Syndrome. As the MHRA continues its review, it is likely that they will implement new safety measures to better protect patients. This may include stronger warnings on packaging, more stringent guidelines for prescribers, or even a re-evaluation of who should be eligible to receive Finasteride in the first place. If you are currently taking finasteride or are considering it, be sure to have an open discussion with your healthcare provider to weigh up the risks vs benefits for you.

We know that hair loss is an intensely personal journey. This is why we created personalised hair loss and regrowth treatments through our online skin clinic. Our doctors create custom hair loss treatments for each and every patient. We also treat skin concerns like acnehyperpigmentationmelasma and signs of skin ageing with bespoke skincare treatments. Start your virtual consultation and begin your journey to great hair today.

Authored by:

Dr Amel Ibrahim
Aesthetic Doctor & Medical Director
BSC (HONS) MBBS MRCS PHD
Founder City Skin Clinic
Member of the Royal College of Surgeons of England
Associate Member of British Association of Body Sculpting GMC Registered - 7049611

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