New Patient Warnings for Finasteride

Significant changes are being made to the information provided with finasteride 1 mg tablets, aimed at safeguarding patient well-being. These tablets, often prescribed for hair loss, will now include explicit warnings about potential sexual function issues, such as decreased libido and erectile dysfunction, which can lead to mood changes including depression or suicidal thoughts.

Patient Cards to Educate Users

To ensure patients are informed, a patient card will accompany each package of 1 mg finasteride tablets. This card will outline the risks and the actions to take should patients experience any concerning symptoms.

Review of Risks Shows Caution is Key

This move follows an extensive review by the Pharmacovigilance Risk Assessment Committee (PRAC) which evaluated the association between finasteride, dutasteride, and suicidal ideation. Although the committee has acknowledged suicidal thoughts as a side effect of finasteride, it concluded that the benefits of these medications still surpass their risks during approved use.

Understanding the Medications

Finasteride 1 mg tablets and finasteride skin spray are primarily used to treat androgenetic alopecia, a condition that causes hair loss due to male hormones. On the other hand, finasteride 5 mg tablets and dutasteride 0.5 mg capsules serve to alleviate symptoms of benign prostatic hyperplasia (BPH), a condition marked by an enlarged prostate that can disrupt urine flow.

Dutasteride: A Precautionary Measure

While no direct link between suicidal ideation and dutasteride was found during the review, due to its similar mechanism to finasteride, health authorities will also update dutasteride's product information to include potential mood changes as a precaution.

Patient Guidance: Take Action!

For those currently on finasteride 1 mg tablets, it's crucial to be aware of mood alterations. If you notice any changes such as depressive feelings or suicidal thoughts, it's imperative to stop the medication and consult your healthcare provider immediately. This caution extends to individuals experiencing sexual dysfunction, as this can also exacerbate mood issues.

Healthcare Professionals: Stay Informed

Healthcare providers are advised to monitor patients using 1 mg oral finasteride for any signs of mood changes or sexual dysfunction. Prompt action and communication are vital to ensure patient safety.

Broader Context on Safety Reviews

The review has stemmed from a directive initiated by the French medicines agency, highlighting an ongoing commitment to patient safety. The PRAC's findings will be integrated into future regulations across the EU, ensuring all medications derived from 5-alpha reductase inhibitors uphold stringent safety standards.

What is Finasteride?

Finasteride works by inhibiting the enzyme 5-alpha reductase, reducing levels of dihydrotestosterone (DHT), the hormone responsible for hair loss and prostate enlargement. The EU has authorized its use under various brand names, catering to hundreds of thousands seeking treatment for these common conditions.