MHRA Issues Patient Alert for Finasteride, Citing Psychiatric and Sexual Side Effects

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a patient alert for finasteride, a drug commonly used to treat male pattern baldness and enlarged prostate, warning of potential psychiatric and sexual side effects. The alert comes amid a three-fold increase in reports of serious adverse reactions since 2020, prompting the agency to advise doctors to screen patients for a history of depression before prescribing the medication.

Why this matters: This alert highlights the importance of monitoring the safety of widely used medications and ensuring that patients are well-informed about potential risks. The consequences of ignoring these side effects can be severe, leading to long-term mental health issues and affecting the quality of life for millions of men worldwide.

Finasteride, which is used by millions of men worldwide, including former US President Donald Trump, works by blocking the conversion of testosterone into dihydrotestosterone (DHT), a hormone that can contribute to hair loss and prostate growth. While the drug has been proven effective in treating these conditions, the MHRA's safety review was triggered by a surge in reports of side effects such as depression, suicidal thoughts, insomnia, low libido, and erectile dysfunction.

Dr. Alison Cave, the MHRA's chief safety officer, emphasized the importance of patient awareness, stating,"It's crucial patients are aware of vital information about the medicines they're taking. "She added that the introduction of patient alert cards in finasteride packets later this year aims to"raise awareness among men taking finasteride"about the potential for psychiatric and sexual side effects, so they can make an informed decision about their treatment and know what to do if they experience these side effects.

The MHRA advises men taking finasteride for hair loss to stop treatment and contact their doctor if they develop depression or suicidal thoughts. Those taking the drug for an enlarged prostate should consult their doctor immediately if they experience such symptoms. Any concerns about sexual dysfunction should also be discussed with a healthcare professional.

Finasteride was originally developed in the 1980s to treat an enlarged prostate and was later found to promote hair growth. Merck & Co, the drug's manufacturer, has denied any link with serious long-term side effects but has paid out millions of dollars to settle lawsuits with patients in the United States. The MHRA has received almost 300 reports of depressed mood disorders and suicidal and self-injurious behaviors linked to finasteride, as well as over 400 reports ofsexual dysfunction.

The patient alert issued by the MHRA underscores the importance of monitoring the safety of widely used medications and ensuring that patients are well-informed about potential risks. As regulatory agencies continue to review the safety profile of finasteride, individuals taking the drug are urged to remain vigilant and seek medical advice if they experience any concerning side effects.

Key Takeaways

• UK's MHRA issues patient alert for finasteride due to psychiatric and sexual side effects.
• Reports of serious adverse reactions have tripled since 2020, prompting doctor screening.
• Finasteride can cause depression, suicidal thoughts, insomnia, low libido, and erectile dysfunction.
• Patient alert cards will be introduced in finasteride packets to raise awareness of potential side effects.
• Men taking finasteride should stop treatment and contact their doctor if they experience side effects.