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The UK medicines regulator has issued updated safety advice for finasteride and dutasteride, strengthening warnings about potential psychiatric side effects and sexual dysfunction following a new review of evidence and a European regulatory review.

The Medicines and Healthcare products Regulatory Agency has updated its guidance after re-examining clinical data, safety reports and expert advice. Finasteride and dutasteride both belong to a group of medicines that reduce the level of a hormone called DHT in the body.

Finasteride is prescribed in two main strengths. A 1mg dose is used to treat male pattern hair loss, which is the most common type of genetic hair thinning in men. A higher 5mg dose is used to treat benign prostatic hyperplasia, which is a non-cancerous enlargement of the prostate that can cause difficulty urinating.

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Finasteride is used to treat male pattern hair loss at a dose of 1mg, and benign prostatic hyperplasia at a dose of 5mg. Dutasteride is a similar medicine that also lowers DHT. In the UK it is given at a 0.5mg dose to treat benign prostatic hyperplasia and help reduce the risk of serious urinary problems linked to an enlarged prostate. It is available as dutasteride alone or in combination with tamsulosin.

The MHRA has published a new Drug Safety Update and is updating product information for medicines containing finasteride and dutasteride to provide clearer guidance for healthcare professionals and patients.

On Monday, the MHRA updated its safety advice to strengthen warnings about potential psychiatric and sexual dysfunction linked to finasteride and to provide precautionary advice on dutasteride. A precautionary warning was added to the product information for dutasteride to note that mood alterations have been reported with a medicine in the same class, finasteride.

These include depression, low mood, suicidal thoughts, and sexual dysfunction such as decreased sex drive, erectile dysfunction and ejaculation disorders.

Doctors are now being asked to discuss these risks more clearly with patients before prescribing these medicines. They are also encouraged to check a patient's mental health history and to monitor for any signs of depression or sexual side effects during treatment.

Patients taking finasteride are advised to stop treatment and seek medical help immediately if they experience depression or suicidal thoughts. Anyone experiencing sexual side effects is also encouraged to speak to a healthcare professional.

The regulator said that although these side effects have been reported, they are not experienced by everyone and the medicines are still considered effective and widely used for both hair loss and prostate conditions. However, it emphasised that patients should be fully informed of the possible risks before starting treatment.

Dr Alison Cave, MHRA chief safety officer, said: "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 1mg 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."