Highlights from the Medicines Safety Committee meeting in September-October 2024 – Farmacija-mic

EZA begins safety review of medicines containing finasteride and dutasteride

The review will assess data on suicidal ideation and behaviour

The National Medicines Agency informs that the European Medicines Agency (EZA) has started a review of the safety of medicines containing finasteride and dutasteride due to concerns about suicidal thoughts and behaviour.

Tablets containing 1 mg of finasteride and finasteride topical solution are used to treat androgenic alopecia (hair loss caused by male hormones) in early stages in men aged 18 to 41 years. Tablets containing 5 mg of finasteride and capsules containing 0.5 mg of dutasteride are used to treat benign prostatic hyperplasia (BPH) in men. BPH – An enlarged prostate gland that can cause urinary flow problems.

During the review, the EZA’s Pharmacovigilance Committee (PRAC) will evaluate all available data on suicidal ideation and behavior related to the use of finasteride and dutasteride. The PRAC will also assess the impact of these side effects on the benefit-risk balance of the medicine, taking into account the health conditions for which the medicine is being used.

Oral medicines containing finasteride and dutasteride have a known risk of psychiatric disorders (side effects), including depression. Recently Propecia and Proscar – the product description of the first two finasteride-containing drugs, which have been registered in several countries of the European Union (EU), included suicidal thoughts as a possible side effect, the frequency of which is unknown.

Medicines containing finasteride already have measures in place to reduce the risk, including warnings in the product information. They require healthcare professionals to monitor patients for symptoms of psychiatric disorders and to stop treatment if such symptoms appear. Patients are advised to seek medical advice if they experience symptoms of psychiatric disorders.

The EZA will assess all available data on suicidal ideation and behavior related to finasteride and dutasteride and make a recommendation on whether the marketing authorizations for these medicines should be maintained, varied, suspended or withdrawn across the EU.

Medicines containing finasteride and dutasteride are evaluated by the EZA Medicines Safety Committee (PRAC)*, in which medicine safety specialists of the State Medicines Agency also participate.

New safety information for healthcare professionals: the potential risk of medication errors associated with Keppra and Levetiracetam UCB changing the oral solution dosing syringe

Keppra and LevetiracetamUCB are medicines used to treat epilepsy alone or in addition to other anti-epileptic medicines.

The EZA Committee on the Safety of Medicines (PRAC) discussed the letter to healthcare professionals (HCPs) about the medicine Keppra and Levetiracetam UCB 100 mg/ml oral solution for use in children aged 6 months to 4 years (150 ml bottle), dosing syringe included in the package for volume changes. The 3 ml dosing syringe will be replaced by a 5 ml dosing syringe. VVAS will provide information to health care professionals about the possible risk of medication errors in connection with changes in the volume of the dosing syringe.

When prescribing and dispensing levetiracetam (Keppra and Levetiracetam UCB) oral solution with the new 5 ml syringe, healthcare professionals should inform the patient’s caregivers of changes in the volume of the dosing syringe. Caregivers should be informed that although the new 5 ml syringe has 0.1 ml sections, it has an additional 0.25 ml section compared to the 3 ml syringe. Caregivers should be instructed on the correct dose and how to measure it with a 5 ml syringe. Caregivers should be advised to read the instructions provided in the package leaflet on how to recognize the signs and symptoms of levetiracetam overdose and what to do in such a situation.

VVAS by Keppra and Levetiracetam UCB will be referred to the EZA Committee for Medicinal Products for Human Use (CHMP). After that, the owner of the registration certificate will send VVAS to healthcare professionals, following the agreed communication plan. VVAS will be published on the website Direct healthcare professional communications (VVAS for healthcare professionals) and in the drug registers of the EU member states.

We invite you to see more information about what PRAC has done On the website of the European Medicines Agency – here (in English).

Specialists of the Latvian State Agency of Medicines also participate in the scientific committees of the European Medicines Agency, including the Medicines Safety Committee.

* PRAC – EZA Pharmacovigilance Risk Assessment Committee, or abbreviated – Medicines Safety Committee.

Source: ZVA

Finasteride and Dutasteride: A Hair-Raising Safety Review!

EZA Launches Safety Review – Because Who Doesn’t Love a Good Scare?

Ah, finasteride and dutasteride, the dynamic duo sent to save the day for hair loss and prostate problems! For men aged 18 to 41 trying desperately to hang onto what little hair they have left, it’s the ultimate blend of hope in a pill. But it seems our pharmaceutical friends at the European Medicines Agency (EZA) have decided it’s time for a closer look at these trusty medications. Why? Apparently, they’ve taken a keen interest in the *not-so-pleasant* correlation between these medications and suicidal ideation and behavior. Yes, you heard that right! Nothing says “let’s tackle hair loss” like a side order of existential dread.

According to the National Medicines Agency, the EZA has kicked off a safety review packed with all the suspense of a thriller – will it be a happy ending or a dramatic cliffhanger? They’ll be diving deep into the effects of finasteride (like Propecia) and dutasteride (think Avodart) and assessing the evidence on those pesky dark thoughts, pondering whether our brave soldiers fighting against male hormones might end up a bit too dejected.

Hair today, gone tomorrow – but at what cost?

Let’s break it down. Finasteride, the 1 mg version is your go-to for androgenic alopecia, which is basically a fancy way of saying, “You’re losing your hair!” And don’t get me started on the 5 mg version intended for benign prostatic hyperplasia. If only they had a potion for “an enlarged ego” – then we’d really be in business! But alas, it turns out that while they’re saving heads, they could also be messing with minds. Who knew hair treatments came with a psychological twist?

The EZA’s dedicated squad, the Pharmacovigilance Risk Assessment Committee (PRAC) – or as I like to call them, the official buzzkill brigade – will evaluate all that delightful data on suicidal thoughts and behaviors linked to these meds. After all, depression has a way of sneaking up on you while you’re busy admiring your receding hairline. So they’re not just twiddling their thumbs; they’re making sure that when it comes to health benefits versus risks, we’re not missing a beat!

We’ve got warnings – And not just about the weather!

Hold your horses, folks! Let’s not forget that finasteride has a safety net of warnings already stitched into its product info. Healthcare professionals are virtually required to channel their inner Sherlock Holmes, keeping a watchful eye on anyone taking these medications for signs of psychiatric distress. Frankly, if my hair loss medication came with a side of doom and gloom, I’d be expecting to see a therapist *and* a stylist on speed dial!

For those already riding the finasteride rollercoaster, they’re urged to consult a healthcare professional if their mood takes a nosedive. Remember, folks: you can always regrow your hair, but your mental health? Well, that’s a bit trickier!

And just when you thought it couldn’t get weirder…

Now, let’s shift gears to another riveting piece of news – a potential risk of medication errors linked to The Great Syringe Switcheroo with Keppra and Levetiracetam UCB, two heavyweight champs in the fight against epilepsy! Yes, because why not stir the pot even further with a syringe upgrade? They are swapping out the trusty 3 ml dosing syringe for a 5 ml. Just try saying that three times fast without getting tongue-tied!

This little change could lead to confusion among caregivers, and in the world of epilepsy treatment, confusion is like putting on roller skates before a tightrope walk. Caregivers are going to need instructions clearer than a morning after in the pub – and don’t even get me started on how to recognize the signs of an overdose! It’s not exactly the most fun dinner conversation, is it?

So there you have it, folks! With the EZA gearing up to sift through the ominous clouds looming over finasteride and dutasteride, one can only hope that whatever conclusions are drawn help keep our minds as well as our heads intact. Hair today, but let’s at least keep the brains blissfully happy!

Stay safe, stay informed, and remember, the next time you’re popping a pill for that hairline of yours, perhaps give your mind a quick check-in too! Because if you can’t hair the solution, don’t lose your head over it!

Source: ZVA

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