Health authorities in the UK have issued a new safety warning for some widely used hair loss drugs, following concerns that they could be linked to serious psychological and sexual side effects.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has warned men taking finasteride, a daily tablet used to treat male pattern baldness, to be aware of the potential risks. The drug has been linked to mood disorders, depression, suicidal thoughts and sexual dysfunction, the agency said.
A preliminary warning has also been placed on dutasteride, a similar drug used primarily to treat symptoms of an enlarged prostate.
In 2024, the MHRA required finasteride suppliers to include a patient information card in the drug's packaging to raise awareness of these risks. These measures remain in place.
Warning cards highlight the potential risk of erectile dysfunction, decreased libido, depression and suicidal thoughts. Patients taking the drug for hair loss are advised to stop taking it immediately if they experience such symptoms. Those taking it for an enlarged prostate should contact their doctor immediately.
Dr. Alison Cave, chief safety officer at the MHRA, said that following a detailed review of the available evidence, the information on finasteride 1 mg and dutasteride has been strengthened so that patients and healthcare professionals have clearer guidance on the potential risks.
Finasteride, also sold under the trade names Proscar and Propecia, is used to treat both hair loss and an enlarged prostate. However, on the British public health system, the NHS, it is only available for prostate treatment.
The drug works by blocking the conversion of testosterone into dihydrotestosterone, DHT, a hormone that can affect prostate enlargement and hair loss.
An enlarged prostate is a common condition in men over 50 and is usually not considered serious. However, when the prostate enlarges, it can put pressure on the urethra, causing difficulty urinating. The most common symptoms include a weak urine stream, taking longer to empty the bladder, and a more frequent or urgent need to urinate, including at night.
Finasteride has long been linked to mood disorders and sexual function problems, but the MHRA has recently reviewed all available data to strengthen safety measures for patients.
"Patient safety is our top priority. We expect physicians to discuss relevant safety information with patients so that they can make informed decisions about their treatment," said Dr. Cave.
The British regulator added that 170 cases of suicidal thoughts or similar terms have been reported to the Yellow Card scheme, which allows patients and healthcare professionals to report suspected side effects from medicines, for finasteride. Of these cases, 19 have been fatal.
After reviewing the reports, experts have concluded that stopping the drug does not always lead to the disappearance of side effects. In some cases, sexual function problems can persist even after stopping treatment.
Previously, the MHRA had recommended that patients share the warning card with family or friends, who may more easily notice changes in mood or behavior.
Prescription data shows that over 400 prescriptions are issued each month for finasteride 5mg and medicines containing dutasteride. Meanwhile, finasteride 1mg, which is used for hair loss, is not currently prescribed by the NHS and can only be obtained by private prescription, so there is no accurate data on the number of users. /GazetaExzpress/
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