MHRA Toughens Safety Advice for Hair Loss & Prostate Drugs

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced updated safety advice to strengthen warnings regarding potential psychiatric and sexual dysfunction associated with finasteride. 

The regulatory body has also introduced precautionary advice for dutasteride, a similar medication in the same drug class.

This move follows an additional, detailed review of available evidence, which included the results of a European regulatory review under Article 31 and expert advice provided by the Commission on Human Medicines. 

As a result, the MHRA has published a new Drug Safety Update and is currently revising the product information for medicines containing these active ingredients to ensure healthcare professionals and patients receive clearer guidance.

Finasteride is primarily used in two different capacities, depending on the dosage. At a 1mg dose, it is prescribed to treat androgenetic alopecia, commonly known as male pattern hair loss. 

At a higher 5mg dose, it is used to manage benign prostatic hyperplasia (prostate enlargement). 

Dutasteride, administered at a 0.5mg dose, is also used to treat benign prostatic hyperplasia.

Updated product information and warnings

The latest updates involve significant changes to the product information for these treatments. 

For finasteride 1mg used for hair loss, the warnings have been strengthened to clarify that sexual dysfunction may contribute to the development of mood disorders. 

Furthermore, the update specifies that sexual dysfunction has been reported in patients both with and without accompanying mood alterations.

While the primary focus of recent evidence has been on finasteride, the MHRA has also taken a proactive approach to dutasteride. 

A precautionary warning has been added to the product information for dutasteride 0.5mg, noting that mood alterations have been reported with finasteride, which belongs to the same class of medication.

These new measures build upon previous safety actions taken by the UK regulator. 

Following a safety review in 2024, the MHRA introduced patient alert cards for finasteride.

These cards remain in place and are designed to highlight the risks of depression, suicidal thoughts and sexual dysfunction. 

They provide vital instructions to patients on what to do if they experience any of these side effects during treatment.

Support for informed decision-making

Dr Alison Cave, MHRA Chief Safety Officer, emphasises the importance of these updates in promoting patient safety and informed consent. She says: “The MHRA has taken significant action to raise awareness of the risks of sexual dysfunction, depression and suicidal thoughts associated with finasteride, including issuing a Drug Safety Update and introducing patient alert cards in 2024.

“Following an additional detailed review of the evidence, we have now strengthened product information for both finasteride 1 mg and dutasteride to provide clearer guidance on these potential risks and to support informed discussions between healthcare professionals and patients.

“Patient safety is our top priority. We expect prescribers to discuss the relevant safety information with patients so they can make informed decisions about their treatment, and we continue to encourage patients and healthcare professionals to report suspected side effects through the Yellow Card scheme.”

Guidance for patients and professionals

The MHRA has issued clear instructions for individuals currently prescribed these medications. 

Patients taking finasteride who begin to experience symptoms of depression or suicidal thoughts are advised to stop their treatment immediately and seek medical advice. 

Additionally, any concerns regarding sexual side effects should be discussed with a healthcare professional.

To support ongoing monitoring, the MHRA encourages both healthcare providers and patients to report any suspected adverse reactions. 

These reports can be submitted through the Yellow Card scheme, the UK's primary system for collecting and monitoring information on suspected safety concerns involving medicines and medical devices.